Senior Process Engineer, Advanced Operations

Stryker Corporation•Portage, MI

60d•Onsite

About The Position

Stryker is seeking a Senior Process Engineer, Advanced Operations in Portage, MI. This person will execute 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.

Requirements

B.S in Mechanical Engineering or related engineering discipline with 2 or more years of relevant post-graduate experience
Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
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.

Nice To Haves

Experience in an FDA regulated or regulated industry beneficial.

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.
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 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.