OEM/CM Staff Project Engineer, Advanced Operations

Work Flexibility: Hybrid or Onsite

What you will do -

As a Staff Project Engineer, Advanced Operations (AO) you will work with OEM/CM suppliers to launch new products for the team. You will be working in a variety of products including software, electrical, and mechanical and you will be accountable for the realization involved in the manufacturing of products involving qualifications, process controls, and ERP systems setup required to bring new products to market. You will specify process requirements; supply chain, process design, in-process and finished good inspection/testing required to achieve supply stability to effectively commercialize the product. You will support the activities for the design transfer of products from R&D to Operations. Working with the team you will be responsible for developing and qualifying the manufacturing process for the medical devices developed at Stryker.

Additional responsibilities:

• Define and clarify project scope while developing and maintaining the project schedule
• Have ownership of managing and reporting project progress out to internal stakeholders
• Be responsible for identifying, monitoring, and appropriately managing project risk and liaise with broader AO team on common NPI issues and resolutions
• Establish priorities, imparting a sense of urgency and importance to the team while using project management tools and techniques to support the delivery of new products per cost and time commit
• Create and review process specifications and bill of materials
• Collaborate with internal manufacturing partners, contract manufacturers, designers and product specialist to optimize designs for manufacturability
• Independently determine and develop approaches to a variety of technical problems of moderate scope and complexity
• Use latest 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
• 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
• Provide training for manufacturing team members
• Ensure adherence to GMP and safety procedures
• Review and approval of validation documentation
• Supplier Assessment/Selection (Make vs Buy, Buy vs Buy)

Who we want -

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• 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.
• Effective communicators. People who collect and interpret information accurately and can concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you need -

• Bachelor's degree in engineering required
• 4+ years of experience required
• Experience in project management or leading projects required
• Experience working in a Regulated environment required
• 2+ years of experience in New Product Development- highly preferred
• Experience in qualification and development of Suppliers (PPAPs) - highly preferred
• Medical device experience - highly preferred
• Certified in validation activities - preferred
• Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques - preferred
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing - preferred
• Experience working with suppliers and ERP systems - preferred

Travel Percentage: 20%

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.