3 дня назад
Senior Process Development Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Process Development Engineer (Medical Devices): Lead the end-to-end development and productionization of pull band manufacturing processes with an accent on laser welding, laser cutting, process validation, and ISO 13485 compliance. Focus on optimizing scalable manufacturing solutions, developing technical files and validation studies, and providing technical leadership across NPI programs.
Location: Spiddal, Co. Galway, Ireland
Company
develops and manufactures medical device solutions, including pull band products and related manufacturing processes.
What you will do
- Lead the end-to-end development and productionization of pull band manufacturing processes.
- Develop robust, scalable, and cost-effective solutions using laser welding and laser cutting.
- Collaborate with cross-functional teams on New Product Introduction programs and ensure compliance with ISO 13485.
- Develop and maintain Product Technical Files, risk assessments, and validation studies.
- Use R&R studies, Design of Experiments, equivalence tests, and other statistical tools to optimize and validate processes.
- Lead process validation for the final release of products into commercial manufacturing and mentor junior engineers and support staff.
Requirements
- NFQ Level 8 or higher in a technical discipline such as Mechanical, Manufacturing, Mechatronics, or Biomedical Engineering.
- Ideally 5–7 years of experience in a medical device or pharmaceutical environment.
- Experience working cross-functionally and communicating effectively with people at all organizational levels.
- Certification or training in Lean Six Sigma, Agile Project Management, or similar methodologies.
- Ability to support high-performance and high-engagement NPI teams.
Culture & Benefits
- Commitment to equal opportunity, diversity, and inclusion.
- Participation in continual improvement of occupational health and safety, environmental, and energy management systems.
- Opportunities to contribute to energy conservation and report safety and environmental incidents.
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