Senior Process Engineer, Advanced Operations

Stryker•Portage, MI

2d•Hybrid

About The Position

Stryker is seeking a Senior Process Engineer to join our Advanced Operations team, supporting the Emergency Care Business Unit. In this role, you will have the opportunity to work on the design transfer of new products from research through development and into production. This is a hybrid role based out of Portage, MI. The team works onsite 4-5 days per week to support collaboration and project needs. 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. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical, and surgical, neurotechnology, and spine products to help people lead more active and more satisfying lives.

Requirements

B.S in Mechanical Engineering or related engineering discipline.
2+ years of relevant experience post graduation.
Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams both onsite and remotely.
Innovative thinker - should be able to envision new and better ways of doing things.
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.
Ability to travel internationally.

Nice To Haves

Experience with Lean Manufacturing Principles preferred.
Experience in an FDA or other regulated industry preferred.

Responsibilities

Provide engineering support of process development and introduction by bridging new product development and release to production; while ensuring that all activities are completed and documented in accordance with Stryker’s new product development procedures.
Ensure quality of process and product as defined in the appropriate operation and material specifications.
Analyze equipment to establish operating data, conduct experimental test and result analysis.
Lead and/or participate in process review meetings.
Assist in process and equipment selection for components based on specifications, reliability, and regulatory requirements.
Work with quality engineers to develop component specific testing and inspection protocols.
Support make/buy analysis and recommend sourcing strategies including cost analysis, supplier evaluation, and risk assessment.
Support capital acquisition activities: equipment selection, procurement, installation, and validation.
Develop inspection and test method protocols/equipment and conduct MSA studies.
Conduct experimental process testing and interpret results to analyze process performance.
Participate in the generation and review of PFMEAs, Control Plans, SOPs, process design and PPAPs for product launches both internally and at suppliers.
Ensure adherence to GMP and safety procedures.
Generation, Execution, Review, and Approval of validation documentation.