Senior Process Engineer, Advanced Operations

Stryker•Kalamazoo, MI

2d•$77,700 - $129,500•Onsite

About The Position

Stryker is seeking a Senior Process Engineer to join its OrthoTech Division in an onsite role in Portage, Michigan. The position supports new product and process introductions, process development and validation across the supply chain, and manufacturing quality and compliance. The engineer works with designers, suppliers, manufacturing teams, and other cross-functional partners to deliver project and business needs.

Requirements

Bachelor’s degree in engineering.
At least 2 years of applicable full-time work experience.
Working knowledge of PFMEA.
Strong technical documentation skills and ability to communicate technical details effectively to cross-functional audiences.
Excellent analytical skills and ability to plan, organize, and implement concurrent tasks.
Knowledge of machining, manufacturing, and assembly processes; materials; and product and process design.
Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T).
Ability to learn and apply quality system procedures and best practices.
Strong interpersonal and communication skills for cross-functional internal and external conversations.
Willingness to travel between Stryker engineering and manufacturing sites and key supplier sites as needed.
CAD experience.

Responsibilities

Support new product and process introductions, ensuring activities are completed and documented in accordance with Stryker new product development procedures.
Ensure the quality of processes and products.
Support supply chain architecture and implementation to meet project needs and business strategy.
Own process development and validation for the entire supply chain.
Partner with designers and suppliers to communicate design for manufacturing (DFM), design for assembly (DFA), and design for inspection (DFI) considerations.
Select components and equipment based on specifications, reliability, and regulatory requirements.
Develop testing and inspection equipment and protocols.
Lead or support capital acquisition activities, including equipment specification, contract negotiation, installation, and validation.
Analyze equipment to establish operating data, conduct experimental tests, and analyze results.
Lead and/or participate in process review meetings.
Own process risk documentation, including PFMEA and PCP, and validation planning and execution according to Stryker quality system requirements.
Complete engineering studies, including DOE, MSA, and capability studies, for component and assembly manufacturing and inspection processes.
Provide training for manufacturing team members.
Ensure adherence to GMP and safety procedures.