- Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
- Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
- Builds productive internal and external working relationships and may periodically provide guidance and train other team members.
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the company's new product development procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- All other duties as assigned.
- May involve prolonged periods of sitting or standing, as appropriate.
- May be required to reach, push, or pull in order to accomplish job requirements.
- Must be able to review printed materials.
- Must be able to communicate with large groups of people.
- Must be able to communicate telephonically.
- Must be able to use common office equipment (e.g. calculator, PC, fax machine, etc.)
- Must be able to observe and correct minute inconsistencies.
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