Software Quality Engineer

About the Role

Key Responsibilities

• Work with new product development teams to ensure software used in development, manufacture, and as part of medical devices is developed and validated according to good design practices and regulatory requirements.
• Improve processes through better tools, practices, and automation where applicable.
• Develop test strategies, methodologies, and tools in collaboration with early technology teams.
• Ensure the quality of software products in the HealthCast portfolio.
• Learn industry requirements for quality systems, security, and software development and validation, and provide guidance to teams to meet these requirements.
• Create risk management plans, perform product risk assessments, facilitate failure mode effects analysis, and generate risk management reports.
• Develop metrics for measuring software reliability and security, evaluate results, and contribute to process improvements.
• Review requirements, architecture, design, code, and other work products with a focus on patient safety, device quality, testability, manufacturability, serviceability, and security.
• Oversee product software verification and manufacturing software validation processes.
• Manage problem-tracking and defect resolution processes.
• Support outsourced software vendor audits and qualification as needed.
• Ensure compliance with FDA Quality System Regulations and internal processes during new product development and changes.
• Learn statistical analysis techniques for sample size determination and test result analysis.
• Review Design History Files and Technical Files for conformance to requirements.
• Assist with internal, external, and supplier audits.
• Provide quality support to facilitate rapid resolution of product complaints and safety issues.

Requirements

• Understanding of software programming techniques.
• Ability to review and understand system and software architectural designs.
• Good verbal (including presentation) and written communication skills.
• Ability to work effectively on project teams.
• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree in Computer Science, Computer Engineering, Electrical Engineering, or related field.

Nice to Have

• Experience developing, modifying, applying, and maintaining standards for software systems quality, operating methods, processes, and procedures.
• Experience conducting evaluation of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation.
• Knowledge of defining measures to ensure product quality and developing operating criteria for software quality programs.
• Experience reviewing software design, change specifications, and plans against contractual and process requirements.
• Experience in verification and validation of software system requirements, traceability, and testability.

Qualifications

• Broad theoretical job knowledge typically obtained through advanced education.
• A Baccalaureate degree in a relevant field (e.g., Computer Science, Engineering).

Benefits & Perks

• Competitive salary and flexible benefits package.
• Salary range for U.S. locations: $64,800 - $97,200.
• Eligibility for short-term incentive (Medtronic Incentive Plan).
• Health, Dental, and Vision insurance.
• Health Savings Account, Flexible Spending Account, Life insurance, Long-term disability leave.
• Dependent daycare spending account, Tuition assistance/reimbursement.
• Additional benefits including incentive plans, 401(k) with employer contribution and match, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan, Capital Accumulation Plan.