Mahwah, NJ, United States
Engineering, Quality, Cad
Who We Want
We are looking for a driven and detail-oriented individual that has a passion for Quality and New Product Development! You will be an advocate for integrating quality into our innovative designs.
and join a team of self-motivated, independent and creative thinkers. We work together and cross functionally ensuring product excellence. Our team works within the Design Assurance function and your role will have significant interaction with PD, Marketing and Operations.
What you will do
As a Senior Engineer, Design Assurance you will lead design control activities and risk management processes throughout the new product development process. Being a part of this team means that you are working cross functionally to drive our companies’ mission and strengthen the Stryker brand. You should love solving novel problems in fast paced and stimulating environment.
You will work supporting 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 participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigates those issues throughout the development process.
You will be an influential partner for R&D to drive safety and performance in new products
You must be effective in communication related to implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
What you need
Bachelor’s Degree in Mechanical or Biomedical Engineering preferred – related discipline also considered
Minimum of 3 years’ experience design assurance tools such as FMEA (Failure Mode Effects Analysis, GD&T, Root Cause Analysis and Poke Yoke/Mistake Proofing highly preferred
Strong regulated environment experience; medical device, military or aerospace etc
Strong experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues highly preferred
Work From Home: No
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.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com
Website : http://www.stryker.com