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 *****, 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 collaborationRisk-based engineering decision making
Clear and effective technical communication
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