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Staff Engineer, Advanced Operations

Who we want- 

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Dedicated achievers. 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, data and insights to drive continuous improvement in functions.
Stryker’s Sustainability Solutions Advanced Operations team is seeking to hire a Staff Engineer, Advanced Operations to work on new product introduction process development in Chandler, Arizona.
What you will do-

  • Provide engineering support and leadership for product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker product procedures
  • Ensure quality of process and product as defined in the appropriate operation and material specifications
  • Lead the specification, development and implementation of manufacturing equipment based on analysis of specifications, reliability and regulatory requirements
  • Analyze equipment and processes to establish operating data and conduct experimental test and result analysis
  • Lead and participate in process review meetings
  • Evaluate process layouts in terms of supporting new process integration while ensuring best utilization of floor space ensuring optimum process flow
  • Lead and participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
  • Conduct process validations and measurement systems analysis (MSA) studies for new products and new processes
  • Review and approve validation documentation
  • Drive and execute effective communication with all stakeholders to enable project success
  • Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
  • Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
  • Lead creation and refinement of engineering documentation
  •  Provide training for manufacturing team members
  • Ensure adherence to good manufacturing practices (GMP) and safety procedures
What you need- 

  •  Bachelor's degree in Engineering or related field required
  •  4+ years of experience required
  • Strong technical ability to develop and optimize designs to incorporate design for manufacturability (DFM) principles required
  • Experience with engineering development, including installation qualification, operational qualification, performance qualification (IQ/OQ/PQ), or equivalent experience required
  • Good knowledge of manufacturing processes, materials, product and process design required
  • Experience in developing and implementing manufacturing processes and equipment required
  • Leading and coordinating team efforts through projects required
  • Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) - highly preferred
  • Experience planning, reviewing and executing process validations-  highly preferred
  • Six Sigma Green Belt or higher - highly preferred
  •  Experience in a FDA regulated or medical device and/or biotech field -highly preferred