Software Quality Assurance Engineer II

About the role

Starkey is seeking a Software Quality Assurance Engineer II at its global headquarters in Eden Prairie, MN. This position ensures the quality of software/firmware used in Starkey products and adherence to software quality assurance standards and global regulatory requirements. The role leads software quality assurance and compliance by applying Design Controls identified in the product risk management file throughout the product lifecycle (Advanced Development, Product Development, and Product Manufacturing). A key partner to Research Development, Regulatory, and Marketing, this role focuses on maintaining a high standard of product quality that conforms to global standards and regulatory requirements, with an emphasis on patient safety and reliable product performance.

Responsibilities

• Software Quality Assurance – New Product Development
  • Ensure software and firmware follow recognized international standards and regulations applicable to medical devices through the product lifecycle.
  • Help define Software/Firmware use cases and develop test strategies in collaboration with Software and Firmware development teams to ensure product performance and delivery of intended function.
  • Understand medical device risk management concepts and their application to product firmware/software.
  • Understand concepts of Software and Firmware integration testing of medical devices to ensure proper connectivity with other devices/apps.
  • Help define testing strategies for Software/Firmware use cases to verify meeting of requirements and validate the desired output.
  • Partner with Design Engineering on new product development. Participate in design reviews, establish quality requirements, and coordinate qualification testing.
  • Collaborate with software/firmware design teams in developing system requirements and critical-to-quality and safety requirements.
  • Communicate any project or process issues in a timely manner.
• Software Quality Assurance – Non-product software
  • Ensure non-product software systems are validated using a risk-based approach aligned with regulatory expectations (e.g., FDA CSA guidance).
  • Define intended use, risk assessments, and acceptance criteria for software systems.
  • Develop and execute validation deliverables (e.g., plans, protocols, summary reports).
  • Ensure validation documentation includes justification, risk rationale, and traceability.
  • Ensure software systems meet requirements for data integrity, traceability, and record retention within the QMS.
  • Collaborate with Quality and Regulatory to ensure systems support compliance with standards (e.g., ISO 13485, 21 CFR Part 820/Part 11 where applicable).
  • Maintain inspection-ready documentation for internal and external audits.
• Organizational Improvement
  • Implement new operational tools and methods to improve product quality and operational efficiency.
  • Drive awareness of issues and organize teams to address them as appropriate.
  • Partner with cross-functional development teams to ensure adherence to the NPI process.
  • Escalate non-conformances as identified.
  • Support and mentor cross-functional teams to ensure sound, systematic problem-solving methodologies are used to identify, prioritize, communicate, and resolve quality issues throughout the product lifecycle.
• Other duties/responsibilities as assigned.

Requirements

• Education
  • At least a 4-year college degree (M.S. preferred) in Computer Science/Software/Electrical/Electronic Engineering or equivalent.
• Experience
  • Minimum 5 years of software development or quality assurance.
  • Experience with Operations, Customer Service, Sales, and/or Marketing business functions desired.
  • Experience testing application integration functionality desired.
• Knowledge / Technical Requirements
  • Knowledge of Software development lifecycle principles.
  • Knowledge and understanding of software design, architecture, and development.
  • Knowledge of IEC 62304.
  • Knowledge of ISO 13485.

Skills

• Excellent analytical and problem-solving skills.
• Excellent people skills.
• Strong collaboration skills.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience).
• Judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects.

Working Conditions

• Standard office conditions.
• Less than 5% travel.
• Equipment Operation:
  • Computer and associated spreadsheet/word processing software.
  • Software simulators.
  • Electrical test equipment.

Pay

The target rate for this position is between $78,540 to $107,000/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

• 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, and paid volunteer service day.
• Paid paternity and maternity leave.
• Tuition reimbursement.

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