Senior Process Development Engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s 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\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions.\n\nAdvancing possibilities for a brighter tomorrow\n\nBoston Scientific is seeking a highly motivated Senior Process Development Engineer on a permanent basis to join our team.\n\n \n\nJob Purpose:\n\nThe Senior Process Development Engineer will lead the development, characterisation, validation, and industrialisation of electronics\u2011enabled manufacturing processes for catheter\u2011based medical devices. \n\nThis role requires strong electronics and PCB integration expertise, combined with demonstrated technical leadership and mentoring of engineers in a regulated medical device environment.\n\n \n\nKey Responsibilities:\n\nProcess Development \u0026 Electronics Integration \n\n * Lead development and optimisation of electronics\u2011related manufacturing processes for catheter systems, including PCB, flex circuits, wire assemblies, sensors, and electrodes. \n * Provide technical leadership on PCB and electronics integration into catheter assemblies, including DFM/DFA input to R\u0026D. \n * Partner with suppliers on PCB fabrication, electronics assembly, and component qualification. \n\n\n\nValidation, Quality \u0026 Compliance \n\n * Own and execute Process Validation (IQ/OQ/PQ) and Test Method Validation activities. \n * Author and approve PD documentation including PCs, PRAs, MVPs, MIs, and validation reports. \n * Ensure compliance with ISO 13485, FDA QSR, and internal quality systems. \n\n\n\nManufacturing Support \u0026 Continuous Improvement \n\n * Act as escalation point for electronics\u2011related manufacturing issues, leading root cause investigations and corrective actions. \n * Drive process robustness, yield improvement, and reliability enhancements. \n\n\n\nTechnical Leadership \u0026 Mentoring \n\n * Mentor and technically develop junior and mid\u2011level engineers within the Process Development organisation. \n * Provide technical direction and coaching on electronics\u2011related process challenges. \n * Lead or co\u2011lead PD workstreams, setting technical strategy and standards. \n * Act as a subject matter expert (SME) for electronics processes within catheter programs.\n\n\n\n \n\nEducation \u0026 Experience:\n\n * Level 8 Hons Bachelor Degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or related discipline. \n * 7+ years experience in Process Development / Manufacturing Engineering within medical devices or another regulated industry. \n * Demonstrated hands\u2011on experience with electronics\u2011enabled medical devices, ideally catheter\u2011based systems. \n * Direct experience with electrophysiology, diagnostic, or therapeutic catheters. \n * Strong experience in PCB design and/or PCB integration (rigid and/or flex). \n * Experience with flex circuits, embedded electronics, sensors, or high\u2011voltage signal systems. \n * Supplier management experience for outsourced PCB or electronics manufacturing. \n * Exposure to regulatory submissions, audits, or design reviews. \n * Experience leading PD engineers or technicians in a formal role. \n * Familiarity with statistical tools (DOE, Minitab, capability analysis). \n * Experience supporting NPI through pilot and commercial launch. \n * Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk management activities. \n * Experience authoring and approving regulated technical documentation (PCs, PRAs, MIs, validation reports). \n * Demonstrated mentoring or technical leadership experience (formal or informal). \n * Strong structured problem\u2011solving and data\u2011driven decision\u2011making skills. \n * Ability to work cross\u2011functionally with R\u0026D, Quality, Manufacturing, and Suppliers.\n\n\n\n \n\nAs a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \u2013 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 \u2013 as a global business and as a global corporate citizen.\n\nSo, choosing a career with Boston Scientific isn\u2019t just business, it\u2019s personal. And if you\u2019re 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!\n\nTo search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers\n\nAt 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 [email protected]\n