Senior Process Development Engineer

Hero Recruitment; Galway; On-site; EUR 70,000 - 90,000; Full time

Job summary

Hero Recruitment is seeking a Senior Process Development Engineer to lead the development and validation of electronics-enabled manufacturing processes for catheter-based medical devices in Galway, Ireland. The ideal candidate will have strong PCB integration expertise and be proficient in mentoring engineers.

This role involves overseeing process validation, driving improvements in manufacturing processes, and ensuring compliance with regulatory standards. Candidates must have a Level 8 Hons degree and significant experience in the medical device industry.

Qualifications

• 7+ years experience in Process Development / Manufacturing Engineering within medical devices.
• Demonstrated experience with electronics-enabled medical devices.
• Strong experience in PCB design and/or integration.

Responsibilities

• Lead development and optimisation of electronics-related manufacturing processes.
• Own and execute Process Validation activities.
• Drive process robustness, yield improvement, and reliability enhancements.

Skills

Electronics integration expertise

Technical leadership

Process development

Mentoring

Problem-solving skills

Data-driven decision making

Education

Level 8 Hons Bachelor Degree in Electronics Engineering

Tools

Minitab

Job description

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.