Engineer, Design Assurance in Mahwah, NJ at Stryker Corporation

Date Posted: 2/2/2020

Job Snapshot

Job Description

JD for Engineer, Design Assurance PSS

Who We Want

We are looking for a driven and detail oriented individual that has a passion for Quality and Patient Specific Solutions. 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 Design, Regulatory Affairs and Operations.

What you will do

As an Engineer, Design Assurance you will lead design control activities and risk management processes throughout the patient specific design process.  Being a part of this team means that you are working cross functionally to drive our company’s mission and strengthen the Stryker brand. You should love solving novel problems in fast paced and stimulating environment.

What you need

  • Bachelor’s Degree in science, engineering or a related discipline
  • Experience in 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 preferred.
  • Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria preferred.
  • Demonstrated ability to effectively work cross-functionally with other departments to drive safety and performance preferred.
  • Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues preferred.    
  • Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process. 

Work From Home: Not available

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.

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