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Senior Medical Device Product Specialist
3 weeks ago
Job Overview:
Pale Blue Dot Recruitment is 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.
Main 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.
- Solid understanding of design controls, validation, and regulatory compliance (e.g., FDA, ISO).
- 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.
