Senior Process Development Engineer

IrishJobs

Galway, Galway, Ireland

Galway, Galway, Ireland

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Advancing possibilities for a brighter tomorrow Boston Scientific is seeking a highly motivated Senior Process Development Engineer on a permanent basis to join our team. 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. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! To search and apply for open positions, visit: At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.

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Galway, Galway, Ireland

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