Senior Engineer, Design Assurance Engineering Sustaining (Hybrid) - New Jersey, Mahwah 325 Corporate Dr

Work Flexibility: Hybrid

Senior Engineer, Design Assurance Engineering Sustaining (Hybrid)

Stryker is hiring a Senior Design Assurance Engineer in Mahwah, NJ, OR Weston Florida, OR Kalamazoo MI to support our Joint Replacement business.

Who we want

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, efficiency, change, and outcomes.
• 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.

What you will do

As a Senior Design Assurance Engineer, you will lead Sustaining Quality Engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality. Senior Design Assurance Engineers efficiently drives rigor in Sustaining activities through creative problem solving and ensures market continuity of safe and effective products.

You will also provide guidance to and work with the Sustaining Product Development, Regulatory, and Manufacturing teams to ensure compliance to the company’s quality system and external standards.

• Work closely with the Product Development team to ensure that product designs meet quality requirements such as safety, effectiveness; participate in customer preference testing and apply learnings towards usability.
• Lead risk management activities for existing portfolios by developing risk management plans, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• Monitor compliance to Stryker’s Quality Procedures and FDA Quality System Regulations (QSR’s) as well as all other product specific standards/regulations and guide the team as necessary.

What you need

Required Qualifications

• Bachelor’s degree in engineering; Biomedical or related discipline
• 2+ years of experience as a Quality Engineer (QE) or an Engineer
• Computer proficiency with Mini-tab or similar analysis program
• Experience within medical device product development life cycle, including risk management, usability engineering and design/ process verification & validation

Preferred Qualifications

• Demonstrated ability to read and interpret CAD drawings.
• Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
• Demonstrated ability to advocate product excellence and quality.
• Knowledge of Medical Device Regulation
• Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Regulatory and Marketing. 
• NC/CAPA experience

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.