Position Summary
- Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products.
- Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
Key Areas of Responsibility
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyse 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.
Qualifications Knowledge Skills
- B.S in Mechanical Engineering or related engineering discipline with 2 or more years' experience
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product and process design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
- Excellent attention to detail.
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