Senior Engineer, Advanced Operations (Advanced Manufacturing/NPI)
Posted on: 21 Feb 2021
Tempe, AZ
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:
* You will use engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
* You will 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.
* You will ensure quality of process and product as defined in the appropriate operation and material specifications.
* You will support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
* You will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
* You will 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.
* You will complete capability studies for in process inspection and generate subsequent Inspection documentation.
* You will conduct process validation and MSA studies for new products and new processes.
* You will drive and execute effective communication with all stakeholders to enable project success.
* You will provide manufacturing team members.
* You will review and approval of validation documentation.
WHAT YOU NEED:
* Bachelors degree in engineering - required
* 2+ years 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
Stryker
Kalamazoo, MI
Stryker Corporation operates as a medical technology company. The company operates through three segments: Orthopaedics, MedSurg, and Neurotechnology and Spine. The Orthopaedics segment provides implants for use in hip and knee joint replacements, and trauma and extremities surgeries. The MedSurg segment offers surgical equipment and surgical navigation systems, endoscopic and communications systems, patient handling, emergency medical equipment and intensive care disposable products, reprocessed and remanufactured medical devices, and other medical devices for use in various medical specialties.
The Neurotechnology and Spine segment provides neurotechnology products that include products used for minimally invasive endovascular techniques; products for brain and open skull based surgical procedures; orthobiologic and biosurgery products, such as synthetic bone grafts and vertebral augmentation products; and minimally invasive products for the treatment of acute ischemic and hemorrhagic stroke. It also provides spinal implant products comprising cervical, thoracolumbar, and interbody systems for use in spinal injury, deformity, and degenerative therapies.
The company sells its products to doctors, hospitals, and other healthcare facilities through company-owned subsidiaries and branches, as well as third-party dealers and distributors in approximately 80 countries. Stryker Corporation was founded in 1941 and is headquartered in Kalamazoo, Michigan.
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IndustryInformation Technology
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No. of Employees36, 000
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Website
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Jobs Posted1486
