Provide process engineering support for new product and process introductions, ensuring that all activities are completed and documented per Stryker design transfer procedures. Participate in PFMEA, Control Plan, SOP and PPAP generation associated with new product launches. Ensure quality of process and product as defined in the appropriate operation and material specifications. Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory r... more details
Work Flexibility: Hybrid
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.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
As the Senior Process Engineer, Advanced Operations you will have the opportunity to work on the design transfer of new products from research through development and on into production. This is a hybrid role based out of Leesburg, VA.
What you will do:
Provide process engineering support for new product and process introductions, ensuring that all activities are completed and documented per Stryker design transfer procedures
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with new product launches
Ensure quality of process and product as defined in the appropriate operation and material specifications
Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements
Support capital acquisition activity including equipment selection, procurement, installation and validation
Analyze equipment to establish operating data, conduct experimental test and result analysis
Participate in process review meetings
Develop inspection and test method protocols/equipment
Conduct MSA studies for new products and processes
Be proficient with and mentor others in usage of industry standards, including design requirements, manufacturing, and test strategies per applicable regulations
Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success as a leader on the team
Deliver high quality results with passion, energy and drive to meet business priorities
Build relationships and influence across the engineering groups within the business
What you need:
Bachelor's degree in Engineering or related technical discipline, required
Minimum of 2years of relevant work experience required
Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing, required
Understanding of electrical components and manufacturing methods, including common failure modes, required
Proficiency in the use of CAD and/or other design and analysis tools, required
Ability to interpret and analyze system drawings with basic Mechanical/Software/Electrical Interactions, required
Electronics circuit board and/or electro-mechanical system manufacturing experience, preferred
Ability to interpret, analyze, and test electrical designs, preferred
Experience in an FDA-regulated or regulated industry, preferred
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.