Senior Process Engineer, Advanced Operations
$77.7k - $129.5kStryker Orthopaedics
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Engineer, Process Development to join our OrthoTech Division. This is an onsite position in Portage, MI.
What you will do:
- Support 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.
- Support supply chain architecture and implementation to deliver on project needs and business strategy.
- Own process development and validation for the entire supply chain.
- Partner with designers and suppliers to communicate DFM, DFA, and DFI considerations.
- Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
- Develop testing and inspection equipment and protocols.
- Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Own process risk documentation (PFMEA, PCP) and validation planning/execution per Stryker quality system requirements.
- Complete engineering studies (DOE, MSA, capability, etc.) for component and assembly manufacturing and inspection processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
What you need:
- Bachelor’s degree in engineering required
- 2+ years of applicable full-time work experience required
- Working knowledge of PFMEA required
- Strong technical documentation skills with ability to communicate technical detail effectively to a cross-functional audience.
- Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
- Good knowledge of machining/manufacturing/assembly processes, materials, product and process design required
- Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
- Ability to learn and apply quality system procedures and best practices.
- Strong interpersonal & communication skills for cross-functional internal and external conversations.
- Willingness to travel between Stryker engineering and manufacturing sites, as well as key supplier sites, on an as-needed basis.
- CAD experience
United States of America Pay Ranges:
- USN : $77,700 - $129,500 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
$77.7k - $129.5k
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