Senior Process Engineer, Advanced Operations

Work Flexibility: Hybrid or Onsite

Who we want

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, 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, information, use cases, and industry analyses to develop best practices.
• Effective Communicators. People who excel at communicating technical concepts effectively and building relationships

What you will do

As the Senior Engineer, Advanced Operations you will provide process engineering support for new product launches in neurosurgical instruments; working with Marketing, R&D, Operations, Advanced Sourcing, Advanced Quality, and Validation teams.  They serve as the voice of operations in the development process and work on design for manufacturability and assembly. This position is responsible for process design, development, and validation in new product development. Job responsibilities include:

• Working closely with internal and external contract manufacturers to develop processes for electro-mechanical assembly including PCBA manufacturing, potting, conformal coating, soldering, pressing, laser welding, laser marking, torquing and manual assembly.
• Leads or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
• 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.
• Analyze equipment to establish operating data, conduct experimental test and result analysis.
• Lead and/or participate in process review meetings.
• Lead and develop Process Failure Mode and Effect Analysis (PFMEA), Control Plan, SOP and Production Part Approval Process (PPAP) generation associated with launches. 
• Development, review, and approval of validation documentation.

What you need

• Bachelor’s degree (B.S.) in Mechanical or Electrical Engineering or related engineering discipline required.
• 2+ years of experience in a manufacturing or R&D environment required.
• Understanding of Design for Manufacturing (DFM), Mechanical Fixture Design, Injection Molding, PCBA manufacturing, potting, conformal coating, soldering, pressing, laser welding, laser marking, torquing and manual assembly preferred.
• Experience in a FDA regulated or highly regulated industry preferred.
• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.

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.