Senior Design Quality Engineer - NPD in San Jose, CA at Stryker Corporation

Date Posted: 10/7/2020

Job Snapshot

Job Description

We are seeking a Senior Design Quality Engineer - NPD in San Jose, CA.

What we want:

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

The Senior Design Quality Engineer - NPD serves a key role for new product development/ R&D team 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 all over the world 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 and all over the world continue to meet and exceed customer needs. Whether helping turn voice of customer into user needs, evaluating risk of new products, creating inspection criteria, 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.

What you will do:

  • Defining User Needs: Help translate voice of customer feedback to design user needs.
  • Defining Functional Specifications: Understand how to take a user need to a quantifiable specification (ex. Force, output, time, etc.)
  • 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.
  • Inspection Methodology: Develops, researches, and identifies methods for inspection of raw materials, components, and finished products at suppliers and within internal manufacturing facilities.
  • 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).
  • Design Reviews: Presents designs for peer review to improve the quality of a design and share best practices.
  • Project Documentation: Key reviewer of project documentation relating to design, compliance, and product testing. Final approver on product launch documentation, sending request to senior management to approve product release for sale.
  • 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:

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 2 years’ experience working in quality, manufacturing, engineering, NPD, pharmaceutical, or highly regulated environment

Preferred Qualifications:

  • Bachelor’s Degree in Science or Engineering (Electrical, Mechanical, Bio Medical or Physics preferred)
  • Candidate does not need to be proficient in all areas but must be proficient in some and be able to demonstrate being a quick learner.
  • Some Quality Assurance training desired.
  • Hands on engineering experience in field of expertise
  • Demonstrated pattern of learning and self-improvement.
  • Ability to build relationships and interact with a diverse and international project team
  • Ability to deal with adversity and find creative solutions to design and testing obstacles
  • Independent judgment; this is a highly autonomous position.  Need to work on projects with general direction and minimal guidance but have the good judgment to reach out for help or peer technical review when appropriate.
  • Strong problem solving and analytical skills.
  • Ability to effectively communicate technical terms to a non-technical audience.
  • Ability to effectively and completely communicate technical details for design documentation.

Why Stryker?  “It’s the people.” That’s the answer you’ll hear most often when you ask our employees why they love working here. Come join our team in San Jose, CA at Stryker!

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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