Job Description
What you will do-
As the Senior Project Engineer-- Advanced Operations you will have the opportunity to work on the design transfer of new products from R&D into production. You will also be responsible for managing suppliers and working with internal teams such as Sourcing, R&D, and Operations to ensure products are developed and launched with precision.
- Additional Responsibilities:
- 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
- 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
- Lead and/or participate in process review meetings
- Assist in management of contract manufacturers for multiple engineer projects
- Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches
- Conduct supplier audits
- Ensure adherence to GMP and safety procedures
- Review and approval of validation documentation
- What you need-
- Bachelor’s degree in engineering - required
- Minimum of 2 or more years of engineering experience - required
- Experience in the medical electronics / healthcare IT industry - highly preferred
- Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques - highly preferred
- Experience in R&D, new product development or process design - highly preferred
- Experience in an FDA regulated or regulated industry - highly preferred
- Knowledge of manufacturing processes, materials, product and process design - highly preferred
- Ability to read and interpret engineering drawings and can understand geometrical dimensioning and tolerancing - highly preferred
- Good instincts and sound judgement for electro-mechanical and structural design
- A professional who is organized and detail-oriented with good interpersonal communication skills
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