Engineer, Design Assurance - Sustaining

Work Flexibility: Hybrid

Engineer, Design Assurance - Sustaining

Mahwah - NJ

Stryker is hiring a Design Assurance Engineer - Sustaining, in Mahwah - NJ to support our Joint Replacement division.

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 Design Assurance Engineer, you will support Sustaining Quality Engineering activities in the maintenance of orthopedic products to ensure the highest level of product and process quality. 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 support the Sustaining Product Development, Regulatory, and Operations teams to ensure compliance to the company's quality system and external standards.

What you need

Required Qualifications

• Bachelor's Degree in Engineering; Biomedical, Mechanical, or related discipline
• Computer proficiency with Mini-tab or similar analysis program
• Demonstrated ability to read and interpret CAD drawings

Preferred Qualifications

• Highly preferred experience within medical device product development life cycle, including risk management, usability engineering and design/ process verification & validation.
• 2+ years of experience as a Quality Engineer (QE) or Engineer in a regulated design environment
• Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62366-1 and ISO 14971
• Knowledge of Medical Device Regulation
• 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
• Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Regulatory and Marketing.
• Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
• Demonstrated ability to work well in the gray, navigating creative solutions through cross functional collaboration
• NC/CAPA experience 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.