Stryker Staff Quality Engineer, Design Assurance – Materials Engineering in Mahwah, New Jersey
Who We Want
We are looking for a driven and detail oriented individual that has a passion for Quality and New Product Development. 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 Staff Quality Engineer, Design Assurance you will lead design control activities, materials engineering and risk management processes throughout the new product development process. You will support the innovation process by analyzing new materials and applications make recommendations for use in new products. 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.
What you need
Minimum of 5+ years’ experience in materials development, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
Bachelor’s Degree in Metallurgical or Materials Science Engineering
Leadership 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.
Leadership in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
Strong leadership and participation 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.
Influential partnership with R&D to drive safety and performance in new products
Previous experience in leading data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
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: No
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.
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