Staff Design Quality Engineer (Mechanical)

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

Job summary

Stryker Corporation is seeking a Staff Design Quality Engineer (Mechanical) in Portage, MI to provide quality support for new product development and cross-functional collaboration across R&D, Operations, and Suppliers. Key responsibilities include leading risk management activities, design verification and validation, and PPAP planning while ensuring compliance with ISO 13485 and ISO 14971.

Candidates should have 4+ years in quality or engineering and a strong background in mechanical design

Qualifications

• Bachelor’s degree in Mechanical Engineering or related discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.
• Preferred experience in medical device/manufacturing industry.
• Familiarity with ISO 13485 and ISO 14971.
• Data analysis experience (statistical analysis, sampling plans, statistical process control, Minitab).
• Advanced quality tools such as FMEA, GD&T, tolerance analysis, RCA, and mistake-proofing.

Responsibilities

• Partner with R&D to ensure mechanical designs meet safety and usability requirements.
• Lead risk management plans, reviews, and implementation of design and process controls.
• Support PPAP planning and communicate PPAP requirements to suppliers.
• Collaborate with Operations and suppliers to implement robust process controls for components and manufacturing processes.
• Contribute to verification and validation through design reviews and final reports.

Skills

Data analysis

Risk management

CAD interpretation

Education

Bachelor’s Degree in Mechanical Engineering

Tools

FMEA

GD&T

Tolerance analysis

Root Cause Analysis

Mistake Proofing/Poke Yoke

Minitab

Job description

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.

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.