Staff Design Quality Engineer (Mechanical)

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

Job summary

Stryker is seeking a Staff Design Quality Engineer (Mechanical) for Portage, Michigan to support the 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 validation, and PPAP activities, while collaborating with R&D, Operations, and Suppliers to ensure robust process controls and compliant design outputs.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related engineering discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.
• Experience in medical device/manufacturing industry (preferred).
• Familiarity with ISO 13485 and ISO 14971 (preferred).
• Data analysis experience (statistical analysis, sampling plans, SPC, Minitab).
• Advanced Quality tools: FMEA, GD&T, tolerance analysis, Root Cause Analysis, Mistake Proofing/Poke Yoke; ability to read CAD models, drawings, specs, and inspection requirements.
• Six Sigma Certification (preferred).
• ASQ CSQE certification (preferred).

Responsibilities

• Partner with R&D to ensure mechanical designs meet quality requirements for safety, effectiveness, reliability, manufacturability, and usability.
• Lead risk management activities for new product development by creating plans and reports and verifying controls.
• Collaborate with Operations and suppliers to implement robust process controls for mechanical components and manufacturing processes.
• Participate in design reviews and track how design features mitigate risks throughout development.
• Lead design validation activities, including human factors usability engineering and evaluation against user needs.
• Support product design and quality transfers to internal and external facilities.
• Analyze and define critical quality attributes for products and processes via risk analysis techniques.
• Contribute to final design verification and validation reports.
• Support PPAP planning and approval with suppliers.

Skills

Quality engineering

Risk management

Design verification & validation

Process controls

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Tools

Minitab

CAD software

FMEA

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

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