Senior Design Quality Engineer (Mechanical)

Stryker is hiring a S enior Design Quality Engineer (Mechanical) in Portage, Michigan, to support our Medical business. In this role, you will independently execute and own quality engineering activities for defined mechanical workstreams within new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, and Regulatory, throughout the development process. You will be responsible for quality activities within assigned products, components, or suppliers, including risk management, design verification and validation, process controls, design transfer, and post-market quality support through the change control process. You may also contribute to and coordinate quality improvement initiatives within your assigned scope.

 

What you will do

• Partner with R&D to evaluate mechanical product designs against quality requirements for safety, effectiveness, reliability, manufacturability, and usability, and translate customer and market feedback into clear design and quality requirements for assigned workstreams.
• Own risk management deliverables for assigned new product development workstreams, including developing risk management plans and reports, facilitating risk reviews, and verifying the effectiveness of design and process risk controls.
• Execute and coordinate design quality activities for assigned workstreams across requirements, design reviews, drawings, specifications, inspection methods, design verification and validation, and change control to ensure objective evidence supports product acceptance.
• Develop and execute design verification and validation strategies and requirements, including usability activities; review protocols and results; and complete final reports with clear, statistically valid conclusions.
• Partner with Operations and suppliers to develop, evaluate and implement robust manufacturing process controls for assigned mechanical components and assemblies.
• Coordinate product design and quality transfers to internal and/or external manufacturing facilities, including PPAP planning, supplier communication, readiness reviews, and approval of quality documentation.
• Identify and document critical quality attributes within assigned workstreams using risk-based methods and ensure alignment with design outputs and process controls.
• Own PPAP execution for assigned components or suppliers. Communicate PPAP requirements to component suppliers, evaluate submission readiness, and approve PPAP documentation and results within the assigned scope.
• Support quality system maintenance and improvement by identifying procedural updates and implementing effective, sustainable solutions.

What you will need

• Bachelor’s Degree in Mechanical Engineering or a related engineering discipline.

• 2+ years’ experience in quality, manufacturing, new product development, or engineering.

Preferred

• Experience within the medical device or regulated manufacturing industry.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience with statistical analysis, sampling plans, statistical process control, and Minitab.
• Applied knowledge of Advanced Quality tools such as Failure Modes and Effects Analysis (FMEA), GD&T, tolerance analysis, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
• Ability to read and interpret CAD models, engineering drawings, specifications, and inspection requirements.
• Knowledge of polymer materials/processes and performance considerations for medical device applications.
• Six Sigma certification or ASQ certification.

United States of America Pay Ranges:

• USN : $77,700 - $129,500 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.