Senior Engineer, Advanced Operations (Advanced Manufacturing/NPI)
Senior Engineer, Advanced Operations (Advanced Manufacturing/NPI)
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Job Description
WHO WE WANT:
Self-directed innovators.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.
Strykers Sustainability Solutions Advanced Operations team is seeking to hire a Senior Engineer Advanced Operations to work on new product introduction process development in Tempe Arizona.
WHAT YOU WILL DO:
Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements project deadlines and product costs.
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.
Support capital acquisition activity from specifying equipment contract negotiation installation and validation.
Analyze equipment to establish operating data conduct experimental test and result analysis. Lead and/or participate in process review meetings.
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.
Complete capability studies for in process inspection and generate subsequent Inspection documentation.
Conduct process validation and MSA studies for new products and new processes.
Drive and execute effective communication with all stakeholders to enable project success.
Provide training to manufacturing team members.
Review and approval of validation documentation.
WHAT YOU NEED:
Bachelors degree in engineering - required
2 years relevant work experience - required
Lean Six Sigma Green Belt Certification or above - preferred
Writing & Executing Validations experience - preferred
New Product Introduction & Advanced Manufacturing Engineering experience - preferred
Medical Device or regulated experience - preferred
Required Experience:
Senior IC
Employment Type
Full-Time
