Systems Verification Engineer II

Starkey is hiring a Systems Verification Engineer II - Continuation Engineering in Eden Prairie. MN. The Systems Verification Engineer II - Continuation Engineering is responsible for leading the planning, execution, analysis, and documentation of design verification and validation activities for engineering changes to released hearing aid products. This role serves as a technical expert for verification strategies across electrical, mechanical, acoustic, and software modifications, ensuring compliance with product requirements, quality standards, and regulatory requirements. The engineer independently manages complex verification projects, drives test methodology improvements, and provides technical leadership across cross-functional teams throughout the product lifecycle.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what's possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.

Watch this video to see more of what sets Starkey apart.

https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

JOB RESPONSIBILITIES/RESULTS

• Design Verification and Validation

• Lead the development and execution of verification and validation strategies for complex Continuation Engineering Requests (CERs).

• Define comprehensive test methodologies, protocols, risk-based test coverage, and acceptance criteria.

• Independently evaluate product changes and determine appropriate verification and validation requirements.

• Review and approve verification plans, protocols, and reports generated by team members.

• Serve as the technical lead for verification activities involving multiple engineering disciplines.

• Component and Equivalency Qualification

• Lead qualification activities for alternate-source and redesigned components.

• Develop statistically sound test plans and data analysis methodologies.

• Provide technical recommendations regarding product equivalency and component substitutions.

• Support supplier qualification efforts as needed

• Failure Analysis and Troubleshooting

• Lead complex root cause investigations involving field failures, production issues, and product performance concerns.

• Develop experimental approaches to isolate failure modes and verify corrective actions.

• Partner with Engineering, Quality, Manufacturing, and Supplier teams to resolve systemic issues.

• Utilize statistical methods and engineering judgment to identify trends and opportunities for improvement

• Regulatory and Documentation Support

• Author and review verification documentation supporting FDA, ISO 13485, and international regulatory submissions.

• Ensure verification activities align with design controls, risk management processes, and quality system requirements.

• Support audits, inspections, and regulatory inquiries by providing technical verification evidence.

• Participate in DFMEA and risk assessment activities as a subject matter expert

• Technical Leadership and Continuous Improvement

• Mentor and provide technical guidance to team members.

• Lead initiatives to improve verification efficiency, test automation, methodologies, and documentation quality.

• Establish best practices, test standards, and verification frameworks for Continuation Engineering activities.

• Present technical findings and recommendations to engineering leadership and cross-functional stakeholders.

• Drive knowledge-sharing activities and support organizational capability development.

• Other duties/responsibilities as assigned

JOB REQUIREMENTS

Minimum Education, Certification and Experience Requirements

• Education

• Bachelor of Science in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field is required

• Experience

• Minimum 5 years of experience in design verification, product testing, or systems engineering in a product development or manufacturing environment.

• Hearing aid, medical device, or audio/consumer electronics experience preferred.

• Demonstrated experience leading verification activities for complex product changes and cross-functional programs.

Knowledge / Technical Requirements

• Advanced knowledge of design verification, validation, and systems testing methodologies.
• Advanced proficiency with audio analyzers, oscilloscopes, environmental test equipment, and hearing aid test systems.
• Strong understanding of electrical, acoustic, mechanical, and software system interactions.
• Experience with statistical analysis, Design of Experiments (DOE), and data-driven decision making.
• Knowledge of system engineering principles, risk management, system verification, use case development, configuration management, and issue tracking
• Strong understanding of ANSI, IEC, FDA, ISO 13485, and applicable regulatory requirements.
• Experience with risk management tools including DFMEA and hazard analysis.
• Working knowledge of test automation, scripting, or laboratory efficiency tools preferred.
• Advanced proficiency with Excel, Minitab, and technical reporting tools

Competencies, Skills & Abilities

• Advanced troubleshooting and analytical problem-solving skills.
• Ability to independently lead complex technical projects and make sound engineering decisions.
• Strong mentoring and technical coaching capabilities.
• Excellent written, verbal, and presentation communication skills.
• Ability to influence cross-functional teams without direct authority.
• Strong project management and prioritization skills.
• Demonstrated ability to identify and implement process improvements.
• Ability to operate effectively in a fast-paced, highly regulated environment.
• Strong attention to detail while maintaining strategic perspective.

WORK CONTEXT

Working Conditions

• Standard office conditions

Equipment Operation

• Standard office equipment
• Acoustic test chambers, audio analyzers, oscilloscopes, hearing aid test equipment, DVOMs, power supplies, personal computer.

Salary and Other Compensation:

The target rate for this position is between $78,540 to $107,100/year. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Benefits: The following benefits for this position, subject to applicable eligibility requirements, include medical, dental and vision insurance, 401(k) retirement plan with company match, company-paid life and short-term disability insurance, long-term disability insurance, employee assistance plan, hearing aid benefits, Paid Time Off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave and tuition reimbursement

This position is eligible for a bonus based upon performance results. There is no guarantee of payout.