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.
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