Product Development Engineer (Medical Devices)

We are Emblation, an award-winning medical technology company revolutionising healthcare by harnessing the power of microwave energy. Our goal is to enhance traditional treatments by leveraging the advantages of microwave technology to deliver precise, repeatable procedures that lead to better clinical outcomes. Founded in 2007 by our co-founders—now serving as President and Chief Technology Officer—our leadership team brings over 50 years of combined experience in medical technology, driving our innovation and growth.

Job Description: We are seeking an innovative and hands-on Product Development Engineer to join our dedicated and collaborative team. This role is ideal for a proactive, hands-on professional with a passion for product development who is eager to work across the entire product lifecycle. You'll be part of a dynamic team designing and manufacturing cutting-edge medical devices that make a positive impact on the world.

Key Responsibilities:

• Medical Device Design & Development: Design and develop new medical device systems and accessories, incorporating both mechanical and electronic components in compliance with company design control procedures and regulatory standards (ISO 13485, QSR).
• Product Sustaining: Maintain and enhance existing products, addressing regulatory changes, component obsolescence, and customer-driven improvements.
• Design Verification: Develop and implement test protocols, procedures, and test jigs to verify new and updated product designs.
• Design Validation: Support validation activities, ensuring compliance with electrical safety, electromagnetic compatibility, and usability standards.
• Product Transfer to Manufacturing: Collaborate with the Operations team to manage the seamless transfer of products to manufacturing, including defining assembly and test procedures and providing ongoing technical support.
• Quality & Compliance Support: Partner with the Quality department to investigate non-conformances, perform root cause analysis, and implement corrective and preventative actions.

Essential Skills:

• Education: Bachelor's degree (Hons) in Mechanical Engineering, Product Design Engineering, or a related field.
• Experience: 2-5 years of experience in product or systems development, with a focus on mechanical design.
• Technical Proficiency: Skilled in 3D modelling software and technical drawing, with SolidWorks preferred.
• Documentation: Strong knowledge of creating specifications, test plans, and technical reports.
• Development Cycle Expertise: Familiarity with structured product development cycles.
• Communication: Excellent written and verbal communication skills, with a proactive and positive approach.

Desirable Skills:

• Prototyping & Manufacturing: Experience with both low-volume rapid prototyping and high-volume manufacturing processes, such as injection moulding.
• Electronics Knowledge: Basic understanding of electronics, with hands-on experience in soldering or multimeter measurements as a plus.
• Standards & Compliance: Knowledge of risk management (ISO 14971) and other medical device standards, especially ISO 13485 and IEC 60601.
• Design for Manufacturing (DFM): Experience in DFM and managing design-to-manufacturing transfer for various materials and processes.
• Regulated Industry Experience: Familiarity with the medical device industry or other highly regulated sectors.
• Occasional Travel: Ability to travel occasionally, primarily to local Contract Electronic Manufacturing (CEM) partners.
• Quality Management System: Experience working within a Quality Management System (QMS), preferably in accordance with ISO 13485.

What You’ll Get in Return:

• Company pension
• On-site gym
• On-site parking and easy shuttle access from Stirling rail station.

Job Type: Full-time

Pay: £35,000.00-£45,000.00 per year

Work Location: In person