- FDA Regulations
- Research & Development
- Analysis Skills
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Engineer, Advanced Operations to join our Stryker Robotics Division in Kalamazoo Michigan.
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.
What you will do
As the Staff Engineer, Advanced Operations you will 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.
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 or support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
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.
What you need
A minimum of a bachelor’s degree (B.S.) in Mechanical Engineering or related engineering discipline required.
A minimum of 4 years of experience in a manufacturing or R&D environment required.
Previous engineering experience required.
Experience in a FDA regulated or highly regulated industry required.
Proven track record of working in a team-based environment.
Excellent interpersonal skills; able to express ideas and collaborate effectively with multidisciplinary teams.
Innovative thinker; able to envisage new and better ways of doing things.
Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
Good instincts and sound judgement for mechanical and structural design.
Understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques preferred.
Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
Knowledge of manufacturing processes, materials, product and process design required.
Ability to read and interpret complex engineering drawings required.
Work From Home: Not available
Travel Percentage: None
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.