Software Design Assurance Quality Engineer

About the Role

Key Responsibilities

• 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.
• Generate, maintain and update risk management documentation throughout the life cycle of a product.
• Lead the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts.
• Serve as a core team member for validation of software used in the manufacturing process by providing technical leadership and direction. Responsibilities include the completeness and accuracy of change impact assessments, validation compliance with regulation/procedures, change risk assessment sufficiency, and acceptance criteria.
• Work with and manage suppliers as needed during development to support overall program needs.
• Ensure compliance with software / firmware development and non-product software validation procedures.
• Contribute to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.

Requirements

• Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.
• 8+ 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.
• BS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development) preferred.
• Knowledge of pertinent regulations (e.g., ISO 13485, 21 CFR Part 820).
• Strong leadership skills and ability to influence peers and team members.
• Excellent written and verbal communication skills.
• Ability to prioritize and plan activities.

Nice to Have

• Advanced degree or professional certifications.

Qualifications

• BS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development).
• Advanced degree or professional certifications are valued.

Benefits & Perks

• Health benefits - Medical, Dental, Vision.
• Personal and Vacation Time.
• Retirement & Savings Plan (401K).
• Employee Stock Purchase Plan.
• Training & Education Assistance.
• Bonus Referral Program.
• Service Awards.
• Employee Recognition Program.
• Flexible Work Schedules.