Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
Stryker is seeking a Staff Design Quality Engineer in Flower Mound, TX.
Who we want:
Hands-on Engineers. Engineers who can demonstrate mastery over their field and apply their hands-on knowledge to ensure our products will excel in the field.
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 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 design quality
Quality oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions. Design capable Engineers who have the vision to push product designs to their limits to build design quality understanding and improvement.
The Staff Design Quality Engineer serves a key role for new product development/ R&D team at Stryker Communications, a pioneer in operating room integration. The Staff Design Quality Engineer interfaces with all functions of the business, including marketing, R&D, clinical, regulatory, and operations, ensuring that the products designed at our facility in Flower Mound, TX continue to meet and exceed customer needs. By turning voice of customer into user needs, evaluating risk of new products, and performing validation labs in simulated use cases with surgeons, nurses, and specialist customers, this Staff 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. Analyze and define critical quality attributes for product and process through risk analysis techniques.
• 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).
• 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.
• Design Transfer: Support product design transfers to internal and/or external manufacturing facilities.
What you will need:
• BS Degree in Engineering.
• 4+ years of full-time Quality Engineering, NPD, R&D, and/or Design experience
• Bachelor’s in Computer Engineering, Electrical Engineering, Software Engineering or related discipline.
• Master’s in Engineering or related preferred.
• Some Quality Assurance and Design/R&D training desired.
• Previous Medical Device experience highly preferred.
• Previous Risk Management experience highly preferred.
• Hands-on engineering/design ability, highly preferred.
• Blueprint/engineering schematic reading and interpretation.
• Excellent written and oral communication skills.
• Excellent organizational, problem-solving, and analytical skills & ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Proven ability to handle multiple projects and meet deadlines.
• Strong communication, interpersonal, and influencing skills.
• Good judgment with the ability to navigate “the gray”.
• Working knowledge of data collection, data analysis, evaluation, and scientific method.
• Demonstrated mechanical/electrical problem-solving skills.
• Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Includes walking around the plant.
• Must be able to generate, follow, and explain detailed instructions and inspection procedures.
• Must be able to communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel.
• Must be able to analyze and resolve non-routine product issues using independent judgment and inspection equipment.
• Must be comfortable in a surgical/cadaveric setting.
• Must be comfortable and available to travel to customers including operating room environments.
Work From Home: Not available
Travel Percentage: 20%