Staff Design Quality Engineer (Mechanical)

Stryker; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Life and disability insurance

Job summary

Stryker is seeking a Staff Design Quality Engineer (Mechanical) in Portage, Michigan to support our Medical business. You will provide quality support for new product development and partner with cross-functional teams throughout the development process.

You will lead risk management, design verification/validation, and process controls for mechanical components and assemblies, ensuring compliance with quality standards and enabling successful product launches.

Qualifications

• Bachelor’s degree in mechanical engineering or related field.
• 4+ years of quality, manufacturing, new product development, or engineering experience.

Responsibilities

• Partner with R&D to ensure mechanical designs meet safety, effectiveness, reliability, manufacturability, and usability.
• Lead risk management activities for new product development with plans, reports, and risk controls.
• Collaborate with Operations and suppliers to implement robust process controls for mechanical components and processes.
• Participate in design reviews and track mitigation across drawings, specs, and inspection requirements.
• Lead design validation activities, including human factors usability engineering.
• Support product design and quality transfers to internal or external manufacturing facilities.
• Analyze and define critical quality attributes via risk analysis techniques.
• Contribute to final design verification and validation reports.
• Support PPAP planning and PPAP approval with suppliers.

Education

Bachelor's Degree in Mechanical Engineering

Six Sigma Certification

ASQ CSQE certification

Tools

Minitab

Job description

Stryker is hiring a Staff Design Quality Engineer (Mechanical) in Portage, Michigan to support our Medical business.

In this role, you will provide quality support for new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, and Regulatory, throughout the development process. You will support mechanical design quality activities, risk management, design verification and validation, process controls, and post-market quality support through the change control process. You may also support quality improvement projects.

What You Will Do

• Partner closely with R&D to ensure mechanical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, and usability. Support the collection of customer and market feedback to inform design requirements and validate the design as it matures through production launch.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of design and process risk controls.
• Partner with Operations and suppliers to implement robust process controls for mechanical components, assemblies, and manufacturing processes.
• Participate in design reviews and track how mechanical design features, drawings, specifications, documentation, inspection methods, and manufacturing processes mitigate risks throughout the development process.
• Lead design validation activities, including human factors usability engineering and evaluation of mechanical design performance against user needs and intended use.
• Support product design and quality transfers to internal and/or external manufacturing facilities.
• Analyze and define critical quality attributes for products and processes through risk analysis techniques.
• Contribute to the completion of final design verification and validation reports.
• Support PPAP planning, communicate PPAP requirements to component suppliers, and support PPAP approval.

What You Will Need

• Bachelor’s Degree in Mechanical Engineering or related engineering discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.

Preferred

• Experience within medical device/manufacturing industry.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard).
• Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, tolerance analysis, Root Cause Analysis, and Mistake Proofing/Poke Yoke. Demonstrated ability to read and interpret CAD models, drawings, specifications, and inspection requirements.
• Six Sigma Certification.
• ASQ CSQE certification.

United States of America Pay Ranges:

• USN: $89,300 - $148,800 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.