Senior Process Engineer, Advanced Operations

Work Flexibility: Hybrid

Who we want:

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker’s new product development procedures
• Ensure quality of process and product as defined in the appropriate operation and material specifications
• 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.
• Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Work with quality engineers to develop component specific testing and inspection protocols
• Analyze equipment to establish operating data and conduct experimental test and result analysis
• Lead process review meetings
• Lead 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 process validation and MSA studies for new products and new processes
• Work in a hands-on manner at the manufacturing site to lead the implementation of new processes as specified in development
• Provide training for manufacturing team members
• Ensure adherence to GMP and safety procedures
• Review and approval of validation documentation

What you need:

• Bachelor’s degree in engineering required
• 2+ years of applicable work experience required
• Specialization or work experience in plastics or polymers
• Working knowledge of PFMEA required
• Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
• Good knowledge of manufacturing processes, materials, product and process design required
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
• CAD experience

Preferred skills:

• Experience in R&D, new product development, or process design
• Injection molding process development experience
• Experience in an FDA regulated or regulated industry
• Experience with plastic assembly (eg. adhesives, joining methods, welding)
• Ability to read and interpret complex engineering drawings and can understand geometrical dimension and tolerances
• 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 related statistical tools and validation/verification techniques
• CAD experience
• 3D printing experience

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 contractor’s legal duty to furnish information.