Sr. Project Engineer, Advanced Operations

Stryker-posted about 1 year ago
Full-time • Mid Level
Mahwah, NJ
Merchant Wholesalers, Durable Goods
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The Sr. Project Engineer in Advanced Operations at Stryker is responsible for providing engineering support for the New Product Introduction (NPI) process development. This role ensures that all activities are completed and documented according to Stryker's procedures, focusing on quality, compliance, and effective collaboration with stakeholders to deliver business value.

  • Provide engineering support for New Product Introduction (NPI) process development.
  • Coordinate with partners/stakeholders to deliver value to the business through opportunity identification, execution, and solution delivery.
  • 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.
  • Lead/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 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 approve validation documentation.
  • Bachelor's degree (B.S.) in Mechanical or related engineering discipline.
  • 2+ years of work experience.
  • Good knowledge of manufacturing processes, materials, product, and process design.
  • Project Management experience.
  • Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
  • Experience in an FDA regulated or ISO 3485 regulated industry - highly preferred.
  • Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
  • 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
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