Starkey Hearing ยท 2 weeks ago
Sr. Design Assurance Engineer - Onsite
Eden Prairie, MN
Full-time
Onsite
Senior Level
$94K/yr - $128K/yr
7+ years expStarkey Hearing is a world leader in the manufacturing and distribution of advanced hearing technologies. They are seeking a Sr. Design Assurance Engineer to ensure product quality and compliance through the application of Design Controls and Risk management throughout the product life cycle, while collaborating with various departments to maintain high standards of product quality and patient safety.
Health CareMedical DeviceWellness
Hiring Manager
Kelly Sheppard
Responsibilities
Partner with Design Engineering on new product development. Participate in design reviews, establish quality requirements, and coordinate qualification testing
Owns and drive deliverables related to the NPI process: Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives
Technically review product system requirements and identify critical to safety and quality requirements. o Communicate any project or process issues in a timely manner
Develops project quality plans to an appropriate level of due diligence and deliver on time. o Ensure project quality plans are followed through the design and product launch phases
Qualify new components, final assemblies, and custom manufacturing processes. o Ensure product qualifications are completed on time
Partner with the NPI department to ensure the NPI process is followed for critical projects
Support and mentor cross functional teams to ensure sound, systematic problem-solving methodologies are utilized to identify, prioritize, communicate, and resolve quality issues through the product life cycle
Perform Other Duties/responsibilities As Assigned
Qualification
Required
4-year college degree in Engineering or another technical field required
Minimum 7 years of experience in medical device Quality Engineering required
Knowledge and experience with ISO 13485:2016 and ISO 14971: 2019 required
Knowledge of medical device design or manufacturing required
Excellent analytical and problem-solving skills required
Excellent people skills required
Strong collaboration skills required
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Sufficient judgment to make reasonable business decisions concerning quality issues with regard to both economic and quality aspects
Preferred
Six Sigma Blackbelt, Lean Systems, or other continuous improvement methodology experience desired
Knowledge of Process validation, developing inspection plans and process control plans using sampling plans and statistical methods and basic measurement techniques desired
Knowledge of medical device manufacturing desired
Knowledge of new product development systems is desired
Knowledge of mechanical shock, vibration, and environmental testing is desired
Knowledge of acoustic engineering is desired
Knowledge of DOE and SPC techniques desired
Knowledge of Quality Plans desired
Knowledge of new product development systems is desired
Knowledge of quality systems desired
Benefits
Medical, dental, and vision insurance
401(k) retirement plan with company match
Company-paid life insurance
Short-term disability insurance
Long term disability insurance
Employee assistance program
Hearing aid benefits
Paid time off
Paid sick time
Paid holidays
Company
Starkey Hearing
Starkey is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota, USA.
5001-10000 employees
H1B Sponsorship
Starkey Hearing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (10)
2023 (14)
2022 (28)
2021 (23)
2020 (35)
Funding
Current Stage
Late StageLeadership Team
Brandon Sawalich
President & CEO
Recent News
2025-12-15
Medical Product Outsourcing
2025-12-05
2025-11-07
Company data provided by crunchbase