Product Development Engineer

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.

Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce