About The Position

As the Senior Project Engineer-- Advanced Operations, you will have the opportunity to work on the design transfer of new products from R&D into production. You will also be responsible for managing suppliers and working with internal teams such as Sourcing, R&D, and Operations to ensure products are developed and launched with precision.

Requirements

  • Bachelor's degree in engineering - required
  • Minimum of 2 or more years of engineering experience - required
  • Experience in the medical electronics / healthcare IT industry - highly preferred
  • Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques - highly preferred
  • Experience in R&D, new product development or process design - highly preferred
  • Experience in an FDA regulated or regulated industry - highly preferred
  • Knowledge of manufacturing processes, materials, product and process design - highly preferred
  • Ability to read and interpret engineering drawings and can understand geometrical dimensioning and tolerancing - highly preferred
  • Good instincts and sound judgement for electro-mechanical and structural design
  • A professional who is organized and detail-oriented with good interpersonal communication skills

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
  • 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 and/or participate in process review meetings
  • Assist in management of contract manufacturers for multiple engineer projects
  • Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches
  • Conduct supplier audits
  • Ensure adherence to GMP and safety procedures
  • Review and approval of validation documentation
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