Product Development Engineer – Medical Device Industry
We are seeking a highly skilled and motivated Product Development Engineer to join our 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.
Key Responsibilities:
* 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.
Requirements:
* 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.
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 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.