Posted:
9/19/2024, 2:33:12 AM
Location(s):
Kalamazoo, Michigan, United States ⋅ Battle Creek, Michigan, United States ⋅ Portage, Michigan, United States ⋅ Michigan, United States ⋅ Grand Rapids, Michigan, United States
Experience Level(s):
Senior
Field(s):
Mechanical Engineering
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 Instruments Division to be based in Portage, MI.
Who we want:
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do:
As the Senior Engineer, Process Development - Advanced Operations you will provide hands on 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
May lead or 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
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
Use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs
Build productive internal and external working relationships and may periodically provide guidance and train other team members
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures
Review and approval of validation documentation
What You Need:
Bachelor’s Degree in Engineering
2+ years of relevant post-grad work experience
Preferred Skills:
Knowledge of manufacturing processes, materials, product and process design
Ability to read and interpret complex engineering drawings
Electrical/Mechanical Engineering degree
Experience in a FDA regulated or highly regulated industry
Understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques
Website: https://www.stryker.com/
Headquarter Location: Kalamazoo, Michigan, United States
Employee Count: 10001+
Year Founded: 1941
IPO Status: Public
Industries: Biotechnology ⋅ Health Care ⋅ Life Science ⋅ Medical ⋅ Medical Device