Senior V&V Engineer

Company Description 

Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients’ products are both safe and effective for their end users.

We are currently seeking an experienced Senior Verification & Validation Engineer to join our dynamic team. In this role you will lead V&V activities across client programs, from planning through final reports and regulatory submission. The ideal candidate has deep experience verifying and validating medical device hardware, software, and systems under design controls.

Responsibilities:

• Leads V&V planning for medical device programs, defining the strategy, scope, and resources for verification and validation activities.
• Develops verification and validation protocols and reports for system, subsystem, software, and hardware requirements.
• Establishes and maintains traceability between user needs, requirements, risk controls, and test evidence.
• Executes and oversees test activities, including test fixture and test method development, and test method validation.
• Develops risk-based test rationales and statistically justified sample sizes.
• Performs software verification activities in compliance with IEC 62304, including unit, integration, and system-level testing.
• Coordinates and reviews external testing, including IEC 60601 electrical safety and EMC, biocompatibility, wireless coexistence, usability, and cybersecurity testing.
• Manages anomaly tracking and resolution, working with development teams to assess and close defects.
• Supports design reviews and technical reviews, and provides V&V input to design and risk management activities.
• Prepares V&V documentation for regulatory submissions and supports responses to FDA and Notified Body questions.
• Collaborates with clients and cross-functional teams, including systems engineering, software development, quality assurance, and regulatory affairs.
• Stays current with industry trends, standards updates, and best practices to continuously improve our V&V services.

Qualifications:

• Bachelor’s degree in an engineering discipline; advanced degree preferred.
• 5 years of experience in verification and validation, with a focus on medical devices.
• Demonstrated experience writing and executing V&V protocols and reports under design controls.
• Experience leading V&V efforts and coordinating work across multiple engineers or projects.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to clients and non-technical stakeholders.

Preferred Skills and Competencies:

• Knowledge of IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, IEC 60601, 21 CFR 820 (QMSR), and FDA guidance on software and cybersecurity in medical devices.
• Experience with connected devices, including Bluetooth, mobile apps, and cloud-based systems.
• Experience with test automation tools and scripting (e.g., Python).
• Experience with requirements and test management tools such as Jira, Jama, or Helix.
• Experience with statistical methods for sampling and data analysis.
• Experience preparing V&V content for 510(k), De Novo, or PMA submissions.
• Experience working under a Quality Management System (QMS).

What We Offer:

• Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
• Opportunity to work with cutting-edge technology across a range of medical device products.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients’ lives.