Senior Design Quality Engineer (Software/Electrical)

Regulatory Toolkit; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker is seeking a Senior Design Quality Engineer (Software/Electrical) for Portage, MI to support Medical Acute Care products. You will ensure quality during development, partner with R&D, manufacturing, suppliers, and regulatory teams, and drive risk management, design verification, and cybersecurity activities throughout the product life cycle.

The role involves leading validation efforts, defining quality attributes, and supporting design transfers to manufacturing sites while contributing

Qualifications

• Bachelor's degree in an engineering discipline is required.
• 2+ years of experience in quality, manufacturing, new product development, software, electrical engineering, or related field.

Responsibilities

• Support quality for new product development and design verification/validation.
• Lead risk management activities and create risk plans/reports.
• Collaborate with Product Security to address cybersecurity in designs.
• Participate in design reviews and ensure documentation and test methods mitigate risks.
• Support PPAP planning and supplier communication.

Skills

Quality engineering

Risk management

Cybersecurity

Data analysis

Education

Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, or a related engineering discipline.

Tools

Minitab

Job description

Work Flexibility: Onsite

Stryker is hiring a Senior Design Quality Engineer (Software/Electrical) in Portage, MI to support our Medical Acute Care 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, Product Security, and Regulatory, throughout the development process. You will support software and electrical design quality activities, risk management, design verification and validation, cybersecurity, process controls, and product design transfer. You may also support post-market quality activities through the change control process and quality improvement projects.

What you will do

• Partner closely with R&D to ensure software and electrical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, cybersecurity, 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 Product Security and R&D to implement cybersecurity best practices and ensure security-related risks and requirements are addressed in the product design.
• Participate in design reviews and track how software and electrical design features, specifications, documentation, test methods, and manufacturing processes mitigate risks throughout the development process.
• Lead design validation activities, including human factors usability engineering.
• Support design verification planning and execution and contribute to the completion of final design verification and validation reports.
• 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.
• Partner with Operations and suppliers to implement robust process controls for electrical components, assemblies, software-enabled systems, and manufacturing processes.
• Support PPAP planning by defining and communicating applicable PPAP requirements to component suppliers, and support PPAP approval.

What you will need

• Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, or a related engineering discipline.
• 2+ years of experience in quality, manufacturing, new product development, software, electrical engineering, or a related engineering field.

Preferred Qualifications

• Experience within the medical device or manufacturing industry.
• Familiarity with ISO 13485 (medical device quality management systems) and ISO 14971 (medical device risk management).
• Experience supporting software and/or electrical product development, design controls, verification, validation, or cybersecurity activities.
• Experience with data analysis, statistical analysis, sampling plans, statistical process control, or Minitab.
• Demonstrated applied knowledge of advanced quality tools such as FMEA, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
• Ability to read and interpret electrical schematics, technical specifications, test requirements, and engineering documentation.
• Six Sigma certification.
• ASQ certification or a master's degree in engineering.

United States of America Pay Ranges:

• USN: $77,700 - $129,500 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.