Starkey is adding a Software Quality Assurance Engineer II at its global headquarters in Eden Prairie, MN. Are you passionate about quality, compliance, and making a difference in patients' lives? Do you have 5 years of software development or quality assurance with knowledge of IEC 62304 and ISO 13485? If so we would love to hear from you. This position is responsible to ensure the quality of the software/firmware used in the Starkey products and adherence to the software quality assurance standards and global regulatory requirements. Lead software quality assurance and compliance by applying Design Controls identified in product risk management file throughout the product life cycle (Advanced Development, Product Development, and Product Manufacturing). Key partner to Research Development, Regulatory, and Marketing. Responsible to provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.
JOB RESPONSIBILITIES/RESULTS- Software Quality Assurance - New Product Development
- Ensures 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 the product firmware/software.
- Understand concepts of Software and Firmware integration testing of medical devices that ensure proper connectivity with other devices/apps.
- Help define testing strategies for the Software/Firmware use cases to verify meeting of requirements and validating 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
- Able to implement new operational tools and methods to improve product quality and operational efficiency
- Skilled at driving awareness to issues and organizing teams to address where appropriate.
- Partner with the cross functional development teams to ensure the NPI process is adhered to. Escalate non-conformances as identified
- Support and mentor cross functional teams to ensure sound, systematic problem-solving methodologies are utilized to identifying, prioritizing, communicating, and resolving quality issue through the product life cycle.
- Other duties/responsibilities as assigned
JOB REQUIREMENTSMinimum Education, Certification and Experience Requirements- Education
- At least a 4-year college degree (M.S. preferred) in Computer Science/Software/Electrical/Electronic Engineering or equivalent required
- Experience
- Minimum 5 years of software development / quality assurance required
- Experience with Operations, Customer Service, Sales, and/or Marketing business functions desired.
- Experience testing application integration functionality desired
Knowledge / Technical Requirement- Knowledge of Software development lifecycle principles required.
- Knowledge and understanding of software design, architecture and development is required.
- Knowledge of IEC 62304 required
- Knowledge of ISO 13485 required
Competencies, Skills & Abilities - 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).
- Enough judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects.
WORK CONTEXTWorking Conditions - Standard office conditions
- Less than 5% travel
Equipment Operation - Computer and associated spreadsheet/word processing software
- Software simulators
- Electrical test equipment
Salary and Other Compensation: 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: 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.
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