Systems Verification Engineer I

Starkey is hiring a Systems Verification Engineer I on its Continuation Engineering team! The Systems Verification Engineer - Continuation Engineering is responsible for planning, executing, and documenting design verification and validation testing for engineering changes to released hearing aid products. This role ensures that all Continuation Engineering Requests (CERs) spanning electrical, mechanical, acoustic, and software changes - are validated against product requirements before release to production. The position works closely with CE Electrical and Mechanical Engineers, R&D, Quality, and Manufacturing to maintain product integrity, regulatory compliance, and performance standards across 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

• Design Verification and Validation

• Plan and execute design verification testing (DVT) to CER-driven changes to released products.

• Define test protocols and acceptance criteria based on product requirements, regulatory standards, and historical performance baselines.

• Perform acoustic, electrical, mechanical, and system-level testing on modified hearing aid designs.

• Evaluate and document test results, ensuring all verification criteria are met prior to release.

• Support design validation activities for significant changes requiring full or partial V&V cycles

• Component and Equivalency Qualification

• Develop and execute component equivalency test plans for alternate-source components (electrical, acoustic, mechanical).

• Analyze test data to confirm that replacement components meet original product specifications.

• Failure Analysis and Troubleshooting

• Support root cause analysis and failure investigation for product issues escalated through CE.

• Perform detailed bench testing and data analysis to isolate failure modes.

• Collaborate with CE and R&D engineers to develop and verify corrective actions.

• Regulatory and Documentation Support

• Generate verification reports, test summaries, and technical documentation supporting CE design control records.

• Ensure all verification activities are conducted in compliance with regulatory requirements (FDA, CE mark, etc.) and Starkey design control procedures.

• Support homologation submissions and regulatory agency reporting with test data and sample preparation.

• Maintain organized and auditable verification records in Starkeys quality management system.

• Cross-Functional Collaboration

• Serve as the primary verification resource on CE project teams, interfacing with Electrical, Mechanical, Quality, Supply Chain, and Manufacturing.

• Participate in DFMEA reviews to ensure test coverage of identified risk areas.

• Present verification results at design reviews and CE project meetings.

• Support knowledge transfer and provide input on test methodology improvements.

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 3 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.

Knowledge / Technical Requirements

• Proficiency with audio analyzers, oscilloscopes, and hearing aid test equipment (e.g., Aurical, GRAS coupler setups).
• Working knowledge of electrical and acoustic measurement techniques.
• Familiarity with hearing aid standards (ANSI S3.22, IEC 60118) preferred.
• Proficiency with MS Office; experience with statistical analysis tools (Minitab, Excel) preferred.
• Knowledge of design control processes, DFMEA, DVT/DVR practices, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Intermediate knowledge of product development best practices (DFM, DOE, Lean PD, etc.).

Competencies, Skills & Abilities

• Excellent analytical and troubleshooting skills with strong attention to detail.
• Strong technical writing and documentation skills for test plans and verification reports.
• Proven ability to work effectively in a cross-functional team environment.
• Ability to work with minimal guidance, manage multiple tasks, and report progress clearly.
• Professional communication and interpersonal skills.
• Excellent verbal, written, and presentation communication skills.
• Self-motivated and able to work in a fast-paced, deadline-driven environment.
• Ability to stay current with new test methodologies, standards, and industry trends.

WORK CONTEXT

Working Conditions

• Standard office conditions

Salary and Other Compensation:

The target rate for this position is between $66,220 to $86,000/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.

#LI-KS1