26 Medical Devices jobs in Ireland

Maintenance - Medical Devices

Cork, Munster Morgan McKinley

Posted 3 days ago

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Maintenance Technician - Manufacturing Location: Cork Schedule: Monday to Friday (On-call rotation included) An exciting opportunity has opened for a Maintenance Technician to join a leading high-precision manufacturing facility. This role is ideal for a hands-on technician with experience in preventative and reactive maintenance, troubleshooting mechanical and electrical systems, and optimising equipment performance in a high-tech production environment. Key Responsibilities: Perform preventative and reactive maintenance on production equipment, including CNC machines, robotics, pneumatics, and hydraulics. Troubleshoot electrical and mechanical issues to minimise downtime and improve efficiency. Work with automation systems, PLCs, and control panels to ensure seamless production. Support continuous improvement initiatives and TPM (Total Productive Maintenance) programs. Manage spare parts inventory, vendor coordination, and maintenance planning. Participate in on-call rotation and respond to urgent maintenance requests. Requirements: Trade qualification in mechanical, electrical, or a related discipline. Experience in a manufacturing or high-precision production environment. Strong knowledge of CNC machines, automation systems, pneumatics, and hydraulics. Hands-on experience with fault diagnosis, repairs, and preventative maintenance. Familiarity with CMMS systems (SAP, Maximo, etc.) for maintenance tracking. Ability to work independently and as part of a team in a fast-paced setting. What's on Offer: Private medical insurance, company pension, and other benefits. Funded training programs (e.g., ABB, Six Sigma) to develop technical skills. A collaborative and high-tech work environment with career growth opportunities. Interested? Apply now or reach out for more details. Skills: Maintenance Electrical Mechanical
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EHS Lead - Medical Devices - Cork

Cork, Munster SSA Recruitment

Posted 6 days ago

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SSA are recruiting an EHS Lead for a site-based role in Cork, within the medical device manufacturing sector. This role is exclusive to local candidates and offers a permanent, high-impact opportunity with a strong focus on safety, compliance, and environmental stewardship. Key Details Position: EHS Lead Sector: Medical Device Manufacturing Location: Cork, Ireland (Onsite; local candidates only) Type: Full-Time, Permanent Salary: €70,000 - €80,000 + Package Full Job Description Our client is a global organisation with a key pharmaceutical / medical device manufacturing site in Cork. Theyre seeking an experienced EHS Leadto embed a strong culture of safety and environmental compliance. This permanent role will give you ownership across training, auditing, incident management, and EHS systems to drive tangible results in a supportive on-site setting. Key Responsibilities Maintain and enhance EHS management systems in line with Irish regulations (HSA, EPA, Local Authorities) Design and deliver site-wide EHS training programmes and inductions Conduct routine inspections, audits, and incident investigations Drive emergency response planning and site preparedness Monitor compliance with national EHS legislation and licensing Prepare and present EHS performance metrics and reports to stakeholders Assess risks associated with plant, processes, and equipment changes Implement waste management and environmental monitoring systems Lead and support continuous-improvement EHS initiatives at site and/or regional level Foster a proactive safety culture, promoting collaboration and best practice Requirements NFQ Level 8 (Bachelors or higher) in EHS, Engineering, or Science Minimum 6 years EHS experience in a manufacturing environment (pharmaceutical focus preferred) Strong knowledge of Irish EHS regulatory landscape and regulator interfaces Proven track record implementing EHS systems and compliance processes Excellent communication, stakeholder management, and influencing skills Relevant certifications or membership in professional EHS bodies (advantageous) Interested? Please emailConor ODonnell at or for a confidential discussion. Skills: EHS Health & Safety EHS Lead Environmental Health & Safety Safety. Environmental Benefits: TBC
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LOTO Engineer - Medical Devices - Cork

Cork, Munster SSA Recruitment

Posted 6 days ago

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SSA are recruiting a LOTO Engineer for an on-site, local-hire role in Ireland, focused on Lockout/Tagout within the MedTech industry. This position is urgent and exclusive to candidates based in Ireland. Key Details Position: LOTO (Lockout/Tagout) Engineer Industry: Medical Devices / Safety Engineering / Compliance Location: Ireland (On-site; local candidates only) Type: Full-Time, Permanent Salary:€60,000 - €70,000& Package Full Job Description Our client is a respected MedTech manufacturer with operations across Ireland. They are now seeking a skilled LOTO Engineer to lead hazardous-energy control during equipment maintenance. This permanent, on-site position will be central to safeguarding staff, patients, equipment integrity, and regulatory compliance. Key Responsibilities Identify and document all energy sources (electrical, mechanical, pneumatic, hydraulic, etc.) Develop and implement detailed Lockout/Tagout procedures for medical and service equipment Deliver training for staff on LOTO protocols; conduct audits to verify adherence Oversee LOTO implementation during maintenance and servicing operations Maintain accurate records of LOTO activities, training sessions, and audits Ensure practices align with OSHA and EU safety and regulatory standards Investigate LOTO-related incidents or near-misses; drive corrective actions Qualifications & Experience Bachelors degree or diploma in Engineering, EHS, or related field 36 years experience managing LOTO programmes in MedTech or manufacturing Strong understanding of hazardous energy control best practice and standards Experience collaborating with maintenance teams and completing safety audits Excellent communication, documentation, and stakeholder engagement skills How to Apply Please reach out to Conor ODonnell at SSA Group for a confidential conversation at or Skills: EHS LOTO Engineering LOTO Safety Environmental Health & Safety Safety Medical Devices
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Quality Engineer I – Medical Devices

H91K2K0 Galway, Connacht Pale Blue Dot® Recruitment

Posted 18 days ago

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full-time permanent

Location: Galway (On-site)
Industry: Medical Device / Start-up
Our client, a dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team. The company is focused on developing innovative, patient-centric technologies to improve quality of life and is advancing rapidly through the product development lifecycle toward global market launch.

This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing Quality Management System. The ideal candidate will enjoy working in a cross-functional, start-up environment and contributing directly to impactful product development.

Responsibilities include but are not limited to the following:

  • Apply quality engineering expertise across the Quality Management System (QMS).

  • Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.

  • Assist with design assurance activities, including design controls, verification, and validation.

  • Support development and validation of test methods and computer system assurance programs.

  • Participate in risk management and usability engineering activities.

  • Maintain document control through QT9 eQMS and perform related administrative tasks.

  • Contribute to the CAPA and non-conformance (NC) investigation and resolution process.

  • Assist in internal and external audits and implement corrective actions as needed.

  • Support updates and gap assessments for applicable regulatory standards and guidance.

  • Participate in supplier quality management, vendor evaluation, and AVL maintenance.

  • Collaborate cross-functionally to uphold quality objectives and continuous improvement.

  • Perform additional quality-related duties to support business goals and KPIs.

  • Bachelor’s degree in engineering, science, or related field (or equivalent).

  • Minimum of 2 years' experience in a medical device or supplier environment.

  • Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements.

  • Experience in both FDA and European regulatory environments is preferred.

  • Strong initiative, problem-solving, and follow-through in executing responsibilities.

  • Understanding of risk management methodologies (ISO 14971).

  • Experience with sterilization (EtO/Gamma), biocompatibility, and transportation testing is a plus.

  • Prior involvement in audits or inspections is an advantage.

  • Proficiency in MS Office and familiarity with electronic QMS tools.

Immediate interviews available for suitable candidates.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other future vacancies

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Tooling & Equipment Design Engineer – Medical Devices

H91K2K0 Tipperary, Munster Pale Blue Dot® Recruitment

Posted 19 days ago

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contract

Location: County Tipperary (On-site)
Contract: 12-Month Fixed Term (with potential for extension)

Our client, a well-established engineering firm, is seeking a Tooling & Equipment Design Engineer to support the development of custom tooling and mechanical systems for implantable medical devices. The role is based on-site at a world-class manufacturing facility in County Tipperary. This is a hands-on, technically challenging role ideal for an experienced mechanical engineer who enjoys precision design, collaboration, and seeing their work make a real-world impact.

Responsibilities include but are not limited to:

  • Design and develop mechanical tooling, fixtures, and assembly equipment to support advanced medical device manufacturing.

  • Create detailed 3D models and engineering drawings using CAD (preferably SolidWorks).

  • Collaborate with manufacturing, quality, and product development teams to ensure seamless integration of new equipment and processes.

  • Participate in design reviews, technical problem-solving, and continuous improvement initiatives.

  • Liaise with external vendors, suppliers, and equipment manufacturers to ensure quality and timely delivery of components.

  • Support the validation and qualification of new equipment and processes as required.



  • 3+ years of mechanical design experience, ideally in tooling, fixtures, or automation within a medical device or regulated manufacturing environment.

  • Strong proficiency in CAD (SolidWorks preferred).

  • Solid understanding of mechanical engineering principles, materials, and production techniques.

  • Proven ability to deliver detailed and accurate mechanical designs within project timelines.

  • Excellent problem-solving skills and attention to detail.

  • Strong communication and teamwork skills.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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Medical Devices Global Regulatory Documentation Manager

Sligo, Connacht Abbott

Posted 7 days ago

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**FIXED TERM CONTRACT**
**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition's global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company.
**MAJOR RESPONSIBILITIES**
+ Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition.
+ Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
+ Develops and implements training programs for individuals involved in medical device activities.
+ Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team.
+ Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.
+ Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
+ Reviews and provides input to product DFMEAs.
+ Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
+ Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
+ Assists in the preparation, review and submission of aggregate safety reports.
+ Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
**EDUCATION & COMPETENCIES**
+ Master's degree in related health science or equivalent skills, education, or experience.
+ RAC certification is a plus.
+ 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
+ Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
+ Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
+ Knowledge of Vigilance reporting regulations on a Global scale.
+ Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
+ Fluency in spoken/written English;
+ Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
+ Excellent communication and interpersonal skills, both written and spoken.
+ Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
+ Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
+ High level of accountability and reliability.
+ Demonstrates ability to work productively as a team.
+ Ability to work in a fast paced, changing environment.
+ Ease of operating in high stress, big decision situations.
+ Continuous improvement mindset.
+ Ability to influence a team in a positive way in relation to performance, change, and culture.
+ Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
+ Mastery of the inventory deployment planning process.
+ Exceptional problem-solving skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
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Laboratory Test Technician (GMP Medical Devices)

Dublin, Leinster PM Group

Posted 6 days ago

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Overview Who we are PM Group is an employee owned, international project delivery firm with a team of 3,700 + people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. We are looking for a Laboratory Test Technician to join our Medical Device Client's (GMP accredited manufacturer) to join the Research and Development (R&D) team. The successful candidate will have a strong technical knowledge base and experience in laboratory equipment, as well as experience with R&D testing and quality documentation. Responsibilities Daily Responsibilities Product testing to support program milestones. Participate in the generation of laboratory equipment operation, maintenance, calibration, and cleaning SOPs to ensure adherence to approved laboratory procedures. Using the laboratory with adherence to good laboratory practices (GLP) for product testing and good documentation practices (GDP) through planning, performing, monitoring, recording and reporting on product testing. Providing support in testing of root cause investigations on malfunctioning product. Ensuring that all work is carried out in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs). Maintaining the laboratory and equipment to good safe working order and ensure readiness of the laboratory for internal/customer/regulatory inspections within the laboratory. Working as part of a dynamic team to collaboratively reach project targets and milestones. Maintaining appropriate recording and reporting systems on all engineering related matters (calibrations etc). Manage stock, including allocation and removal of products and waste. Qualifications Requirements The successful candidate will have a third level Engineer/Technical/Science qualification. You must have a clear understanding of R&D testing and have experience in a laboratory environment. The ideal candidate will have experience of working with mechanical testing equipment and tools. Ability to work autonomously and meet project deadlines with diligence. Good communications and time management skills. As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. #LI-BW1
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Logistics and Office Coordinator (GMP Medical Devices)

Dublin, Leinster PM Group

Posted 1 day ago

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Overview Who we are PM Group is an employee owned, international project delivery firm with a team of 3,700 + people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners. We are looking for a Logistics and Administrative Coordinator to join our Medical Device Client's (GMP accredited manufacturer) This hybrid role combines logistics coordination with general office administration. The successful candidate will be responsible for managing both domestic and international shipments, ensuring compliance with relevant regulations, and supporting the day-to-day administrative operations of the R&D function. Responsibilities Daily Responsibilities Arrange and coordinate domestic and international shipments, including booking, documentation and tracking. Prepare and verify shipping documentation such as commercial invoices, packing lists, and customs declarations. Ensure all shipping activities comply with regulatory standards (e.g., FDA, MDR, ISO 13485). Liaise with freight forwarders, couriers, and customs brokers to ensure timely and compliant deliveries. Maintain accurate shipping records and support audits and inspections. Track and monitor shipments, proactively resolving any delays or issues. Provide administrative support to the R&D team, including document management, meeting and vendor coordination. Assist with onboarding logistics for new team members and support general office operations. Collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Procurement, and Customer Service. Identify and implement process improvements in logistics and office operations. Perform other duties as directed by the manager or as required to support the business. Qualifications Requirements Bachelor's degree in Logistics, Supply Chain Management, Office Administration, Business, or a related field. Minimum of 1 year of experience in logistics, shipping, or office administration, preferably within the medical devices, pharmaceutical, or healthcare sector. Understanding of shipping regulations, documentation, and international trade compliance. Familiarity with quality and regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and GDP. Strong organizational, analytical, and communication skills. Excellent attention to detail and problem-solving skills. Proficiency in Microsoft Office Ability to manage multiple priorities and work effectively under pressure. As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future. PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know. #LI-BW1
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Senior Quality Engineer (m/f/d) Medical Devices

Cork, Munster Stryker

Posted 7 days ago

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**Job Summary**
As a **Senior Quality Engineer** in our **Trauma Business Unit** , you will help bring innovative, life-changing medical devices to market. Working closely with cross-functional teams, you'll ensure the highest standards of quality and safety throughout the product development lifecycle. At Stryker, you'll make a real impact on patient outcomes, grow your expertise, and be part of a global leader consistently recognized as a Best Place to Work. This role reports to the Senior Manager, Quality Engineering and is based in Freiburg (Germany) or Kiel (Germany) or Cork (Ireland).
**What will you do:**
+ Lead quality assurance efforts throughout the design and development phases of new products.
+ Collaborate with cross-functional teams to manage design requirements, risk assessments, and design history file documentation.
+ Responsible and leading risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership?
+ Support and maintain quality systems in accordance with ISO 13485, QMSR and applicable regulatory requirements.
+ Review and approve technical documentation to ensure compliance with the company's quality system, external standards and country specific launch requirements and to ensure the highest level of product and process quality.
+ Drive issue resolution and support team problem-solving efforts with a focus on design quality and compliance.
+ Drive the definition of design verification and validation test requirements that will ensure appropriate objective evidence will be available to support acceptance criteria are met by providing concise conclusions with statistical validity and graphical support
+ Partner with development and manufacturing teams to ensure design transfer and process validation meet quality standards.
**What will you need:**
**Required:**
+ Bachelor's degree in Mechanical Engineering or equivalent technical discipline.
+ Minimum 2 years of experience in Quality Engineering, ideally in medical device or a similar field within a highly regulated industry (pharma, aerospace, food & beverage). Seniority level can be adjusted based on experience.
+ Demonstrated experience in product development, design controls, and risk management .
+ Strong knowledge of ISO 13485, ISO 14971, QMSR, EU MDR and Quality Concepts (e.g. NC/CAPA).
+ Problem-solving mindset with ability to resolve escalated issues in cross-functional teams.
+ Fluency in English.
+ Excellent communication and stakeholder management skills.
+ Demonstrated ability to advocate for product excellence and quality.
**Preferred:**
+ Experience with design and documentation software (e.g. CAD, PLM, SharePoint, Power BI).
+ Project management skills as well as have the ability to manage multiple tasks simultaneously.
+ Proficiency in German or French is a nice to have.
+ Green or Black Belt Six Sigma certification.
+ Experience working with Notified Bodies or Regulatory Authorities.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity?
**Additional information** ?
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence of minimum 1 day on site at our location in Freiburg OR Kiel OR Cork should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Please?note?that?the?internal?job?title?may?differ?from?the?ad title?
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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Product Development Engineer

Dublin, Leinster Pale Blue Dot® Recruitment

Posted 5 days ago

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full-time permanent

Product Development Engineer – Medical Device Industry

We are seeking a highly skilled and motivated Product Development Engineer to join a fast-paced and innovative medical device team. This role is central to the design, development, and optimization of next-generation medical technologies, involving both hardware and software components. You will work cross-functionally to bring products from concept through to commercialization, ensuring compliance with regulatory standards and a strong focus on patient outcomes.

Responsibilities Include but are not Limited to:

  • Lead product development activities from design and prototyping to testing, validation, and market launch.

  • Collaborate with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth and compliant product development.

  • Partner with Product Management to define product strategies and technical requirements aligned with business goals.

  • Define design inputs, conduct feasibility studies, and contribute to the development of technical documentation including design history files and technical files.

  • Work on embedded systems, firmware, and software development to support fully integrated device functionality.

  • Conduct risk assessments and support the implementation of risk management strategies.

  • Optimize designs for manufacturability, scalability, and performance.

  • Manage the full product development lifecycle and ensure adherence to regulatory and quality requirements.

  • Participate in design reviews and prototype evaluations, offering technical guidance across departments.

  • Troubleshoot and resolve product issues during both development and post-market stages.

  • Degree in Engineering (Biomedical, Mechanical, Electrical, or a related discipline).

  • Minimum of 5 years' experience in product development, preferably in the medical device sector or a closely related field.

  • Strong experience with embedded systems, firmware, and software development.

  • Proven background in taking medical devices from concept to market launch.

  • Solid understanding of design controls, validation, and regulatory compliance (e.g., FDA, ISO 13485).

  • Proficient in both hardware and software product design, prototyping, and testing.

  • Knowledge of mechanical engineering principles, manufacturing processes, and materials.

  • Familiar with risk management techniques (e.g., FMEA) and regulatory documentation practices.

  • Skilled in CAD tools (e.g., SolidWorks, AutoCAD), MATLAB, C/C++, Python, and embedded platforms.

Core Competencies:

  • Strong analytical, problem-solving, and decision-making skills.

  • Excellent communication skills, both verbal and written.

  • Proven ability to work cross-functionally with engineering, regulatory, quality, and commercial teams.

  • Highly detail-oriented, proactive, and adaptable with a continuous improvement mindset.

Preferred & Desirable Qualifications:

  • Experience with auditory or wearable medical technologies.

  • Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 standards.

  • Experience with PLM systems and product lifecycle documentation.

  • Lean/Six Sigma or other continuous improvement methodologies.

  • Ability to mentor and train junior team members.

  • Track record of process and product optimization with risk mitigation.

  • Flexibility to work in a dynamic and evolving environment.

  • Willingness to travel internationally as required.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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