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