Senior Process Development Engineer

Senior Process Development Engineer - Electronics / Catheter Systems

Role 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 (Updated - including mentoring)

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
• 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 (Mandatory)

• 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.

Recruiter Screening Section

✅ Must‑Have Requirements

(Candidates must meet all or the majority of these to proceed)

• Bachelor's 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.
• Strong experience in PCB design and/or PCB integration (rigid and/or flex).
• Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk management
• 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.

⭐ Nice‑to‑Have / Differentiators

(Strong advantages but not mandatory)

• Direct experience with electrophysiology, diagnostic, or therapeutic catheters.
• 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.

Key Competencies

• Technical leadership and ownership
• Mentoring and people development
• Cross‑functional collaboration
• Risk‑based engineering judgment
• Clear technical communication