Staff Design Quality Engineer (Mechanical)

Regulatory Toolkit; Portage (MI); Sur place; USD 89 000 - 149 000; Plein temps

Résumé du poste

Stryker in Portage, Michigan is hiring a Staff Design Quality Engineer (Mechanical) to support our Medical business. You will partner with R&D, Operations, Manufacturing, Suppliers, Testing and Regulatory to drive quality across the development process.

The role emphasizes risk management, design verification and validation, process controls, and post‑market quality support through change control. A Mechanical Engineering degree and 4+ years in quality/NP development are preferred, with

Qualifications

• Bachelor’s degree in Mechanical Engineering.
• 4+ years’ experience in quality, manufacturing, or new product development (NPD).
• Experience in the medical device industry or with ISO standards is a plus.

Responsabilités

• Partner with R&D to ensure mechanical designs meet safety, effectiveness, and usability requirements.
• Lead risk management plans, reviews, and verify risk control effectiveness.
• 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 through development.
• Lead design validation activities including human factors usability evaluation against user needs.

Connaissances

Quality engineering

Mechanical engineering

Risk management

Design validation

Formation

Bachelor’s Degree in Mechanical Engineering

Outils

FMEA

GD&T

Minitab

Root Cause Analysis

Poke Yoke

Description du poste

Work Flexibility: Onsite

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.

Travel Percentage: 10%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.