Staff Design Quality Engineer (Software/Electrical)

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

Job summary

Stryker in Portage, Michigan is seeking a Staff Design Quality Engineer (Software/Electrical) to provide on-site quality support for new product development and cross-functional collaboration with R&D, Operations, Product Security, Testing, and Regulatory.

You will develop electrical/software development plans, support execution, and provide post-market quality support through change control; involvement may include quality improvement projects and supplier process controls.

Qualifications

• Bachelor’s degree in relevant engineering or CS
• 4+ years’ experience in quality, manufacturing, NPD, software or engineering

Responsibilities

• Partner with R&D to ensure product designs meet safety and quality requirements.
• Lead risk management activities and develop risk reports.
• Support design validation and PPAP activities.
• Coordinate with Operations and suppliers to ensure robust process controls.
• Contribute to design reviews and post-market quality support.
• Assist with design and quality transfers to manufacturing

Skills

Quality engineering

Risk management

Product safety

Software/Electrical eng

Education

Bachelor’s Degree in Software/Electrical/CS

Tools

Minitab

CAD interpretation

Six Sigma

Job description

Work Flexibility: Onsite

Stryker is hiring a Staff Design Quality Engineer (Software/Electrical) in Portage, Michigan to support our Medical business. In this role, you will provide on-site quality support for new product development and partner with cross-functional teams, including R&D, Operations, Product Security, Testing, and Regulatory, throughout the development process. You will develop electrical and software development plans, support execution of those plans, and provide 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 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.