New Product Development - Staff Design Assurance Engineer in Mahwah, NJ at Stryker Corporation

Date Posted: 2/11/2020

Job Snapshot

Job Description

Who we want

We are looking for a driven and detail oriented individual that has a passion for New Product Development and product safety. We need you to be an advocate for integrating quality into our innovative designs. You will be joining a team of self-motivated, independent and creative thinkers, we work together and across function ensuring product excellence. Our team works within the Design Assurance function but your role will have significant interaction with PD, Marketing and Operations. 

What you will do

As a Design Engineer, New Product Development you should love solving novel problems in fast paced, innovative and stimulating environment. You will lead design control activities, systems and usability engineering and risk management processes throughout the new product development design process for hip and knee implants. You will formulate and analyze both qualitative and quantitative data to influence partnership with R&D to drive safety and performance in new products.   Being a part of this team means that you are working cross functionally to drive our company mission and strengthen the Stryker brand.

  • You will lead and participate in design reviews (including GD&T, tolerance analysis & dFMEA) by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • You will lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
  • You will define design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
  • You will lead and participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Experience in leading data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues is highly preferred    
  • You must effectively communicate requirements for implementing compliance regulations and standards, including 21CFR820, ISO 13485 and ISO 14971 throughout the design and development process. 

What you need

  • Bachelor’s Degree in Engineering, Biomedical, Mechanical, Electrical or related is required
  • Minimum of 4+ years’ experience in engineering in a highly regulated environment such as medical device, military or aerospace industry

Work From Home: Occasional

Travel Percentage: Up to 25%

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.

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