Director, Software Validation

Overview

Exciting leadership opportunity for a Director of Software Validation within a innovative life sciences organization. Join a team dedicated to advancing high-risk medical device software that enhances patient outcomes. This role offers substantial growth potential, leadership responsibilities, and the chance to shape quality assurance functions in a cutting-edge environment.

About our client

Our client is a dynamic company in the medical device sector, focused on developing and validating complex software solutions for high-impact health applications. Their mission centers on bringing innovative, safe, and reliable products to market that improve patient care and clinical outcomes.

The opportunity (Role summary)

As Director of Software Validation, you will lead validation efforts across critical SaMD products, ensuring compliance with industry standards and regulatory requirements. Reporting directly to senior leadership, you will oversee a team of software quality professionals, define validation strategies, and establish governance policies. The role involves working closely with product development, regulatory, and clinical teams, on-site in California.

Key responsibilities

• Lead validation and verification activities for high-risk medical software, ensuring compliance with international standards like ISO 62304.
• Manage and mentor a team of software quality engineers, fostering a culture of continuous improvement.
• Develop and refine validation policies, procedures, and governance frameworks to support product development and regulatory submissions.
• Collaborate with cross-functional teams to integrate validation into the SDLC, especially for cloud-based SaMD applications.
• Drive risk assessment processes, translating standards into tangible design control validations.
• Partner with regulatory teams to prepare for audits and ensure audit readiness for complex software applications.
• Contribute to strategic planning for future product lines and portfolio expansion.

What you’ll bring

• Extensive experience in medical device software validation, particularly with ISO 62304 and SaMD applications.
• Proven track record leading validation efforts for Class III or high-risk medical device software.
• Strong understanding of SDLC processes for cloud and firmware applications.
• Demonstrated ability to build and execute validation policies, governance, and risk assessments.
• Experience working in collaborative, fast-paced environments with cross-disciplinary teams.
• Relevant certifications or training in medical device quality and validation standards.

Compensation & benefits

This role offers a base salary range of $200,000–$240,000 depending on experience, plus a bonus of 10%, equity options, and other benefits.

Call to action

If you are passionate about leading validation initiatives in medical devices and want to contribute to groundbreaking health technologies, we invite you to apply now. Take the next step in your leadership career and help shape the future of medical software innovation.

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