Senior Software Quality Assurance Engineer

Our customer in the medical device sector is hiring a Senior Software Quality Assurance Engineer for their growing company that develops implantable novel neuromodulation medical devices for the treatment of epilepsy and sleep apnea. This is a fully remote role

This role actively participates in the development of product and non-product (e.g., automated manufacturing test systems) software and firmware, by serving as a core team member.

Job Functions

• Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing).
• Chair the change control board within projects for change requests and defects identified during the course of development.
• Provide valuable technical feedback in code reviews.
• Lead (technical expert) and oversee/approve investigations of software/firmware-related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner.
• Generates, maintains, and updates risk management documentation throughout the life cycle of a product.
• Ensures compliance with software/firmware development and non-product software validation procedures.
• Contributes to successful regulatory audits by coordinating back-room / front-room activities or serving as a subject matter expert.

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Knowledge & Skills

• Experience with developing software or firmware in the medical device industry, including demonstrated proficiency in meeting the requirements of IEC 62304.
• Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits/inspections, and develop and implement plans that will ensure company compliance with regulatory requirements.
• Collaborate with other areas within Quality to achieve quality objectives.
• Exhibit strong leadership skills, showing the ability to influence both peers and other team members.
• Exhibit Excellent written and verbal communication skills.
• Demonstrate an ability to prioritize and plan activities.
• Possesses in-depth knowledge of pertinent regulations (E.G. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meets these requirements and, when necessary, identify compliant, effective, and efficient approaches to fulfilling such requirements. (Note: This is not a Software Test Engineer role.)

Qualifications

Education

• BS in Computer Engineering, Computer Science, Electrical Engineering (with education/experience in software development) preferred, or other related degree. Advanced Degree or professional certifications are valued.
• Experience with implantable medical devices is a major plus.
• Requirements
• 6+ years of experience
• Sustained record of performance during tenure in previous position.
• Has full accountability for representing Quality Engineering on project teams.
• Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections.

Sponsorship: Is NOT available for this position

Compensation: $110,000 - $140,000 DOE plus benefits

Applicants must be authorized to work for any U.S. employer.

Staff Smart, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, genetic information, disability status, or any other characteristic protected by law.