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:
1. Lead product development activities from design and prototyping to testing, validation, and market launch.
2. Collaborate with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth and compliant product development.
3. Partner with Product Management to define product strategies and technical requirements aligned with business goals.
4. Define design inputs, conduct feasibility studies, and contribute to the development of technical documentation including design history files and technical files.
5. Work on embedded systems, firmware, and software development to support fully integrated device functionality.
6. Conduct risk assessments and support the implementation of risk management strategies.
7. Optimize designs for manufacturability, scalability, and performance.
8. Manage the full product development lifecycle and ensure adherence to regulatory and quality requirements.
9. Participate in design reviews and prototype evaluations, offering technical guidance across departments.
10. Troubleshoot and resolve product issues during both development and post-market stages.
Minimum Qualifications:
1. Degree in Engineering (Biomedical, Mechanical, Electrical, or a related discipline).
2. Minimum of 5 years' experience in product development, preferably in the medical device sector or a closely related field.
3. Strong experience with embedded systems, firmware, and software development.
4. Proven background in taking medical devices from concept to market launch.
5. Solid understanding of design controls, validation, and regulatory compliance (e.g., FDA, ISO 13485).
6. Proficient in both hardware and software product design, prototyping, and testing.
7. Knowledge of mechanical engineering principles, manufacturing processes, and materials.
8. Familiar with risk management techniques (e.g., FMEA) and regulatory documentation practices.
9. Skilled in CAD tools (e.g., SolidWorks, AutoCAD), MATLAB, C/C++, Python, and embedded platforms.
Core Competencies:
1. Strong analytical, problem-solving, and decision-making skills.
2. Excellent communication skills, both verbal and written.
3. Proven ability to work cross-functionally with engineering, regulatory, quality, and commercial teams.
4. Highly detail-oriented, proactive, and adaptable with a continuous improvement mindset.
Preferred & Desirable Qualifications:
1. Experience with auditory or wearable medical technologies.
2. Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 standards.
3. Experience with PLM systems and product lifecycle documentation.
4. Lean/Six Sigma or other continuous improvement methodologies.
5. Ability to mentor and train junior team members.
6. Track record of process and product optimization with risk mitigation.
7. Flexibility to work in a dynamic and evolving environment.
8. Willingness to travel internationally as required.
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