Senior Software Design Assurance Engineer
Hologic•Newark, DE
•$97,600 - $152,700
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.
- Ability to mature Quality Management System (QMS) processes using Agile/iterative design controls.
- Hands-on experience in full SDLC for safety-critical applications.
- Advanced project documentation, requirements management, and version control.
- Software security skills, including threat modeling, vulnerability assessments, and penetration testing.
- Excellent communication for cross-functional collaboration and technical presentations.
- 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.
- 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.
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.
- 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.
- Leading design assurance activities, risk management, verification, and validation throughout the product lifecycle.
- Participation 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
