Defining User Needs: Help translate voice of customer feedback to design user needs. Defining Functional Specifications: Translate user needs into quantified specifications. Risk Assessment: Work with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed product, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance. Benchmarking Designs: Gathers and analyzes data... more details
Work Flexibility: Hybrid or Onsite
Stryker is seeking a Senior Design Quality Engineer - NPD in San Jose, CA. The Senior Design Quality Engineer - NPD serves a key role in new product development at Stryker Endoscopy, a pioneer in visualization for Minimally Invasive Surgery (MIS). As the market leader in rigid endoscopy, Stryker continues to set the pace in visualization and instrumentation, allowing surgeons to do more and see more in operating rooms all over the world, every day. The Senior Design Quality Engineer interfaces with all functions of the business, including marketing, R&D, clinical, regulatory, and operations, ensuring that the products designed and manufactured at our facility in San Jose, CA continue to meet and exceed customer needs. Whether helping turn voice of customer into user needs, evaluating risk of new products, or performing validation in simulated use cases with our surgeon, nurse, technician, and specialist customers, the Senior Design Quality Engineer is focused on building quality into the products we sell.
Workplace Flexibility: Candidate must reside within a commutable distance to San Jose, CA but is expected to be onsite at the facility at least 3+ times/week
What we want:
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Strategic thinkers. People who enjoy analyzing data for the purposes of planning, forecasting, advising, budgeting, and reporting.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do:
Defining User Needs: Help translate voice of customer feedback to design user needs.
Defining Functional Specifications: Translate user needs into quantified specifications.
Risk Assessment: Work with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed product, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance.
Benchmarking Designs: Gathers and analyzes data to benchmark and compare the performance of multiple products using specifications or empirical test data.
Usability / Human Factors Engineering: Identifies areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists).
Project Documentation: Key reviewer of project documentation relating to design, compliance, and product testing.
Validation: Create and execute test protocols that ensure our products satisfy user needs in a safe and effective manner.
Customer Support: May work with customers to help solve technical issues that arise in the field.
Complaints and User Issue Resolution: Is a technical resource to troubleshoot problems and ensure that customer satisfaction is achieved through issue resolution.
Customer Interaction: Visits customer sites to observe OR workflow, surgical procedures, and products in use as required to support concept development or issue resolution.
What you will need:
Required:
Bachelor's or master's degree in mechanical or electrical engineering.
Minimum 3 years’ hands on experience in a technical role associated with New Product Development (NPD) quality, Research & Development (R&D), and/or testing within a highly regulated environment such as medical device or aerospace.
?Preferred:
Quality Assurance training.
Demonstrated pattern of learning and self-improvement.
Ability to deal with adversity, find creative solutions to design and testing obstacles, and demonstrate independent judgment by working on projects with general direction and minimal guidance while knowing when to seek help or peer review.
Effective communication of technical details for design documentation and technical terms to a non-technical audience.
Building relationships and interacting with a diverse and international project team.
Strong problem-solving and analytical skills.
73,100.00 to 152,400.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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.
