Senior Manufacturing Engineer - Medical Device
IPG Photonics, Marlborough, MA, United States
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
Responsibilities:
- Responsible for manufacturing processes within a company operated under ISO 13485;
- Setting up manufacturing processes of complex medical instruments through all development phases from design input through verification and validation to manufacturing transfer stages, development and qualification of manufacturing processes and further maintenance;
- Assist in developing product specifications with specific requirements for design for manufacturing and service in coordination with other company departments;
- Coordinate technical part of transfer of company products and instruments from development phases into manufacturing, including further analysis of customer complaints and recommendations;
- Optimization of manufacturing cost for medical devices and instruments;
- Assure products are designed and manufactured to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others;
- Assist in development and maintaining of design history file, PFMEA and other documentation to support product regulatory approval and manufacture.
- Bachelor of Science Degree in Electrical or Mechanical Engineering field.
- Strong knowledge of US and global regulatory requirements for medical devices
- Solid project management skills
- 10+ years of work experience in a fast-paced medical device manufacturing environment, including capital equipment and disposable instruments;
- Thorough approach in development of manufacturing processes of multi-functional medical instruments including mechanical / optical / electronic / fluid control components;
- Coordination of both development and operations teams, work within strict time schedules and budget boundaries, managing multiple suppliers, development and manufacturing partners;
- Experience with modern lean manufacturing practices. Knowledge of MRP / ERP systems;
- Experience verification and validation of special manufacturing processes such as laser welding, sterilization, and packaging;
- Experience implementing full or semi-automation production processes.
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