Staff Design Quality Engineer (Software/Electrical)

Stryker Corporation; Portage (MI); On-site; Confidential; Full time

Job summary

Stryker Corporation in Portage, Michigan is seeking a Staff Design Quality Engineer (Software/Electrical) to ensure product designs meet safety and effectiveness standards. You will partner with R&D, Product Security, and suppliers to drive quality and risk management across the development lifecycle.

The role requires a Bachelor's in Software/Electrical/CS engineering and 4+ years in quality or engineering, with medical device experience preferred.

Qualifications

• Bachelor’s Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering (or other engineering degree with relevant electrical or software experience).
• 4+ years’ experience in quality, manufacturing, new product development, software or engineering.
• Preferred Experience within medical device/manufacturing industry.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard), IEC-62304 (software development life cycle) Data analysis experience.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings.
• Six Sigma Certification.
• ASQ CSQE certification.

Responsibilities

• Partner with R&D to ensure product designs meet quality requirements for safety and effectiveness.
• Support the collection of market feedback to inform design requirements and validate design with customers as it matures through production launch.
• Work with Product Security and R&D to accomplish product security activities and ensure cybersecurity practices.
• Lead risk management activities for new product development teams with risk plans and reports.
• Partner with Operations and suppliers to ensure robust process controls.
• Participate in design reviews and track design, documentation, and manufacturing process risk mitigation.
• Lead design validation activities including human factors usability engineering.
• Support design and quality transfers to manufacturing facilities.
• Analyze and define critical quality attributes for products and processes via risk analysis.
• Contribute to final design verification and validation reports.
• Support PPAP planning and PPAP submission to suppliers.

Education

Bachelor’s Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering

Tools

FMEA

GD&T

Root Cause Analysis

Six Sigma

ASQ CSQE

CAD drawings

Minitab

Job description

Work Flexibility: Onsite Stryker is hiring a Staff Design Quality Engineer (Software/Electrical) in Portage, Michigan to support our Medical business.

What you will do:

• Partner closely with R&D to ensure product designs meet quality requirements for safety and effectiveness.
• Support the collection of market feedback to inform design requirements and validate the design with customers as it matures through the production launch.
• Work closely with Product Security and R&D teams to accomplish product security activities and ensure the design is in line with the cybersecurity required practices.
• 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 risk controls.
• Partner with Operations and suppliers to ensure supplier processes and Stryker manufacturing processes implement robust process controls.
• Participate in design reviews and track how the design, documentation, and manufacturing process mitigate risks throughout the development process.
• Lead design validation activities including human factors usability engineering.
• 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 Software Engineering, Electrical Engineering, or Computer Science Engineering (or other engineering degree with relevant electrical or software experience).
• 4+ years’ experience in quality, manufacturing, new product development, software or engineering.
• Preferred Experience within medical device/manufacturing industry.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard), IEC-62304 (software development life cycle) 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, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings.
• 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.

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. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. 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.