Senior Software Design Assurance Engineer

Hologic • Newark, NJ

6d

About The Position

The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices.

Requirements

• In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems.
• Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems.
• Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA.
• Familiarity with usability principles and IEC 62366 to enhance product safety and effectiveness.
• Knowledge of regulatory and safety challenges for AI/ML in medical devices.
• Proficiency in statistical software (e.g., Minitab) for data analysis.
• Hands-on experience in full SDLC for safety-critical applications.
• Excellent communication for cross-functional collaboration and technical presentations.
• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline with 5+ years of medical device industry experience, or a Master’s degree with 3+ years of experience.
• Proven track record in applying medical device regulations and standards to software projects.

Nice To Haves

• Collaborative approach, working closely with cross-functional teams (R&D, Regulatory, Marketing, Manufacturing Engineering, Quality Engineering).
• Leadership in guiding teams on best practices for software development and compliance.
• Proactive in identifying process gaps, recommending improvements, and supporting continuous improvement initiatives.
• Creative and effective problem-solving, ensuring innovative solutions without compromising quality or compliance.
• Commitment to maintaining compliance with all regulatory requirements and internal policies.

Responsibilities

• Establishing and maintaining robust software design controls.
• Driving rigorous verification and validation processes.
• Collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices.
• Maturing Quality Management System (QMS) processes using Agile/iterative design controls.
• Defining and executing robust software verification and validation (V&V) strategies.
• Integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
• Managing advanced project documentation, requirements management, and version control.
• Implementing software security skills, including threat modeling, vulnerability assessments, and penetration testing.
• Leading design assurance activities, risk management, verification, and validation throughout the product lifecycle.
• Participating in new product development and sustaining product projects, ensuring clear scope and objectives are met.
• Involvement in regulatory inspections and remediation initiatives.

Benefits

• Comprehensive training when you join.
• Continued development and training throughout your career.
• Bonus eligible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior