Project Engineer, Advanced Operations

Work Flexibility: Hybrid

The Project Engineer, Advanced Operations is responsible for process design, development, and validation, while working with a diverse, cross-functional team on new product development. They will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity. They will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. They will build productive internal and external working relationships and may periodically provide guidance and train other team members.

Responsibilities:

• 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.
• Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements.
• Will oversee supplier and contract manufacturer activities such as equipment implementation and process development including any necessary troubleshooting. May also include working with internal and external subject matter experts.
• 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.
• Lead/support production builds at both Stryker and contract manufacturer sites.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Draft, execute, review and approval of validation documentation.
• Must be able to generate, follow and explain detailed proposals and operating procedures (i.e. assembly instructions, inspection procedures, and capital project proposals).
• Must be able to analyze and correct complex product and/or process issues using independent judgement.
• Must be able to routinely make decisions that affect immediate operations.
• Must be able to plan, organize, and implement multiple concurrent tasks.

What you need:

• Bachelors Degree in Engineering; Mechanical, Electrical or Biomedical preferred.
• 0-2+ years related years of experience.

Additionally, you should have experience:

• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
• Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
• Good knowledge of manufacturing processes, materials, product, and process design.
• Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
• Experience in an FDA regulated or regulated industry beneficial.

Travel Percentage: 10%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 contractors legal duty to furnish information.