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 *****, 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.
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