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- Develop, document, SOPs, to support manufacturing process of new product and fulfill design and change controls
- Work with the Design Team to ensure manufacturability and effective design transfer of new products to commercialization.
- Responsible for selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.
- Define tooling and equipment maintenance activities and intervals.
- Create project schedules and provide budgetary input for cost reduction and new product projects. Documents project activities.
- Participate in the selection and qualification of new suppliers. Works closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met.
- Ensure new product manufacturability by conducting research, feasibility testing, and process validation.
- Conduct and document verification/validation/engineering testing.
- Conduct time studies to determine accurate labor standards for products supported.
- Set up workflow routers and bill of materials in ORACLE/AGILE database.
- Generate and implement Engineering Change Orders.
- Provide progress reports to management as required.
- Minimum of a bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field.
- Entry level position or individual with 4-7 years in development of implantable medical devices.
- Must know basic designing with ProEngineer or other design software.
- Must have strong interpersonal and organizational skills, possess multitasking capability, be computer literate, and be able to work independently.
- Basic understanding of GD&T
- ProEngineer or other design software
- ID: #43658717
- State: Massachusetts Boston 02117 Boston USA
- City: Boston
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2022-06-28
- Deadline: 2022-08-26
- Category: Et cetera