Job ID: 7609
Job Title: Senior Manufacturing Engineer – Medical Device
Location: Greater Boston Area, MA
Company Overview: Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. Committed to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.
Position: The Senior Manufacturing Engineer, Medical Device will play a critical role in 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.
Responsibilities:
- Responsible for manufacturing processes within a company operated under ISO 13485.
- Assist in developing product specifications with specific requirements for design for manufacturing and service in coordination with other company departments.
- Coordinate technical part of transferring 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 products, and others.
- Assist in developing and maintaining the design history file, PFMEA and other documentation to support product regulatory approval and manufacture.
Requirements:
- 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 the development of manufacturing processes of multi-functional medical instruments, including mechanical/optical/electronic/fluid control components.
- Experience coordinating both development and operations teams, working within strict time schedules and budget boundaries, and 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.
