My client at the forefront of medical device innovation, specializing in the design, development, and manufacturing of cutting-edge diagnostic solutions. We are seeking a highly skilled Senior Product Design Engineer to join our dynamic team and lead the end-to-end product design process, from concept through to manufacturing and compliance.
Key Responsibilities:
- Lead the design and development of microprocessor-controlled electronic circuits and embedded software environments.
- Design for compliance with FCC, EMC, CE, UKCA, and CB Scheme standards.
- Specialize in optoelectronics, PID temperature control, and related circuitry design.
- Conduct reliability testing and ensure robust product design for manufacturability, usability, reliability, and cost optimization.
- Achieve IVD/medical product compliance for European and USA markets.
- Manage test protocols, test studies scope, and coordination with external test houses.
- Utilize Altium or other schematic capture packages for electronic design.
- Manage multiple projects and activities simultaneously with minimal supervision.
- Ensure product design adheres to standards including 61010-1, 61010-2-101, European and FCC EMC standards, ISO13485, and IVDR.
Qualifications:
- 5+ years of experience in end-to-end product design, from concept to manufacturing.
- Proficient in electronic design for FCC, EMC, CE, UKCA, and CB Scheme compliance.
- Experience in the design, assembly, and debugging of microprocessor-controlled electronic circuits and embedded software environments.
- Knowledgeable in optoelectronics, PID temperature control, and related circuitry design.
- Familiar with reliability testing techniques.
- Experience working in a small company environment.
- Expertise in achieving IVD/medical product compliance for European and USA markets.
- Demonstrated ability to manage multiple projects simultaneously.
- Self-directed with strong technical project management skills and minimal supervision.
- Experience in regulated product development.
- Familiar with product design standards such as 61010-1, 61010-2-101, European and FCC EMC standards, ISO13485, and IVDR.
Why Join Them:
- Be part of a pioneering company in the diagnostic solutions industry.
- Collaborate with a team of dedicated professionals.
- Opportunity to lead and influence the product design and development process.
- Competitive salary and benefits package.
Please apply with you CV.