Senior Process Development Engineer

Job Purpose

The Senior Process Development Engineer will lead the development, characterisation, validation, and industrialisation of electronics-enabled manufacturing processes for catheter-based medical devices.

This role requires strong electronics and PCB integration expertise, combined with demonstrated technical leadership and mentoring of engineers in a regulated medical device environment.

Key Responsibilities Process Development & Electronics Integration

• Lead development and optimisation of electronics-related manufacturing processes for catheter systems, including PCB, flex circuits, wire assemblies, sensors, and electrodes.
• Provide technical leadership on PCB and electronics integration into catheter assemblies, including DFM/DFA input to R&D.
• Partner with suppliers on PCB fabrication, electronics assembly, and component qualification.

Validation, Quality & Compliance

• Own and execute Process Validation (IQ/OQ/PQ) and Test Method Validation activities.
• Author and approve PD documentation including PCs, PRAs, MVPs, MIs, and validation reports.
• Ensure compliance with ISO 13485, FDA QSR, and internal quality systems.

Manufacturing Support & Continuous Improvement

• Act as escalation point for electronics-related manufacturing issues, leading root cause investigations and corrective actions.
• Drive process robustness, yield improvement, and reliability enhancements.

Technical Leadership & Mentoring

• Mentor and technically develop junior and mid-level engineers within the Process Development organisation.
• Provide technical direction and coaching on electronics-related process challenges.
• Lead or co-lead PD workstreams, setting technical strategy and standards.
• Act as a subject matter expert (SME) for electronics processes within catheter programs.

Education & Experience

• Level 8 Hons Bachelor Degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or related discipline.
• 7+ years experience in Process Development / Manufacturing Engineering within medical devices or another regulated industry.
• Demonstrated hands-on experience with electronics-enabled medical devices, ideally catheter-based systems.
• Direct experience with electrophysiology, diagnostic, or therapeutic catheters.
• Strong experience in PCB design and/or PCB integration (rigid and/or flex).
• Experience with flex circuits, embedded electronics, sensors, or high-voltage signal systems.
• Supplier management experience for outsourced PCB or electronics manufacturing.
• Exposure to regulatory submissions, audits, or design reviews.
• Experience leading PD engineers or technicians in a formal role.
• Familiarity with statistical tools (DOE, Minitab, capability analysis).
• Experience supporting NPI through pilot and commercial launch.
• Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk management activities.
• Experience authoring and approving regulated technical documentation (PCs, PRAs, MIs, validation reports).
• Demonstrated mentoring or technical leadership experience (formal or informal).
• Strong structured problem-solving and data-driven decision-making skills.
• Ability to work cross-functionally with R&D, Quality, Manufacturing, and Suppliers.