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Senior Engineer, Process Development Specialist

1 month ago

Battle Creek, Michigan, United States Stryker Full time
Senior Engineer, Process Development

We are seeking a highly skilled Senior Engineer, Process Development to join our Instruments Division in Portage, MI. As a key member of our team, you will be responsible for providing hands-on engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker's new product development procedures.

Key Responsibilities:
  • 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 tests, 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 while 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
Requirements:
  • Bachelor's Degree in Engineering
  • 2+ years of relevant post-grad work experience
  • 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
Benefits:
  • Medical and prescription drug insurance
  • Dental insurance
  • Vision insurance
  • Critical illness insurance
  • Accident insurance
  • Hospital indemnity insurance
  • Personalized healthcare support
  • Wellbeing program
  • Tobacco cessation program
  • Health Savings Account (HSA)
  • Flexible Spending Accounts (FSAs)
  • 401(k) plan
  • Employee Stock Purchase Plan (ESPP)
  • Basic life and AD&D insurance
  • Short-term disability insurance

Stryker is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.