Senior Process Development Engineer – Electronics / Catheter Systems

Galway

Contract role

Role Overview

The Senior Process Development Engineer will be responsible for leading the development, characterisation, validation, and scale-up of manufacturing processes for electronics-enabled catheter systems.

This role requires deep expertise in electronics integration (including PCB and micro-electronics), combined with strong technical leadership in a regulated medical device environment. The successful candidate will also have a working understanding of software systems interfacing with electronic components.

Key Responsibilities

Process Development & Electronics Integration

• Lead the development, optimisation, and industrialisation of manufacturing processes for catheter-based systems incorporating electronic components (e.g. PCBs, flex circuits, micro-electronics, sensors, electrodes, and wire assemblies).
• Provide technical leadership on PCB design and integration (rigid and flex), ensuring robust incorporation into catheter assemblies.
• Contribute Design for Manufacturing (DFM) and Design for Assembly (DFA) input to R&D teams.
• Collaborate closely with suppliers on PCB fabrication, electronics assembly, and component selection/qualification.
• Apply understanding of embedded/software-controlled systems to support integration and troubleshooting.

Validation, Quality & Compliance

• Lead and execute process validation activities (IQ/OQ/PQ) and test method validations.
• Generate, review, and approve technical documentation including Process Characterisations (PCs), Process Risk Assessments (PRAs), Manufacturing Instructions (MIs), MVPs, and validation reports.
• Ensure all activities comply with ISO 13485, FDA QSR, and internal quality standards.

Manufacturing Support & Continuous Improvement

• Act as a technical escalation point for electronics-related manufacturing issues, driving structured root cause analysis and corrective actions.
• Improve process capability, yield, and long-term reliability of electronic assemblies within catheter systems.
• Support transition from development through NPI into commercial manufacturing.

Technical Leadership & Mentorship (Essential)

• Mentor and develop junior and mid-level engineers, providing hands-on technical guidance.
• Lead or co-lead process development workstreams, defining technical direction and best practices.
• Act as a subject matter expert (SME) for electronics and micro-electronic integration within catheter programmes.
• Foster a culture of strong engineering discipline and knowledge sharing.

Candidate Requirements

Essential Experience

• Bachelor’s degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or a related discipline.
• Minimum 7 years’ experience in Process Development or Manufacturing Engineering within medical devices or another regulated industry.
• Proven hands-on experience with electronics-enabled medical devices, ideally catheter-based.
• Strong background in PCB design and/or integration (rigid and/or flex), with exposure to miniaturised or micro-electronic components.
• Demonstrated experience in process characterisation, validation (IQ/OQ/PQ), and risk management.
• Experience authoring and approving regulated technical documentation.
• Track record of mentoring or providing technical leadership.
• Strong analytical problem-solving skills with a data-driven approach.
• Ability to collaborate effectively across R&D, Quality, Manufacturing, and external suppliers.
• Working understanding of software/firmware as it relates to electronic systems integration.

Desirable Experience

• Experience with electrophysiology, diagnostic, or therapeutic catheter systems.
• Knowledge of flex circuits, embedded electronics, sensors, or high-voltage signal applications.
• Experience managing external suppliers for PCB or electronics manufacturing.
• Exposure to regulatory audits, submissions, or design reviews.
• Formal leadership experience managing engineers or technicians.
• Familiarity with statistical tools (e.g. DOE, Minitab, capability analysis).
• Experience supporting new product introduction (NPI) through pilot and commercial launch phases.

Core Competencies

• Technical leadership and accountability
• Mentoring and team development
• Cross-functional collaboration
• Risk-based engineering decision making
• Clear and effective technical communication