- 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
- Will 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
- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation
- Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
- Complete capability studies for in process inspection and generate subsequent Inspection documentation
- Conduct MSA studies for new products and new processes
- Ensure adherence to GMP and safety procedures
- Review and approval of validation documentation
- Bachelor's Degree in engineering required (Mechanical, Electrical, or Manufacturing preferred)
- 4+ years of related experience required.
- Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
- Experience in an FDA (Med Device, Med Tech) regulated or regulated industry (Aerospace, Automotive) highly preferred.
- Experience in executing complex problem-solving techniques related to manufacturing/design technical issues highly preferred.
- Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques highly preferred.
- Good knowledge of manufacturing processes, materials, product and process design highly preferred.
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Staff Engineer, Advanced Operations - Portage, United States - Stryker
Description
Work Flexibility: Onsite
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
We are currently seeking a Staff Engineer, Advanced Operations to join our Orthopedic Instruments Division to be based in Kalamazoo, Michigan.
Who we want:
•Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
•Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
•Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
•Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
•Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do:
As the Staff Engineer you will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity. You will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
As the Staff Engineer you will be responsible for building productive internal and external working relationships and may periodically provide guidance and train other team members.
Additional responsibilities include:
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
