Verification & Validation Manager (MedTech)

TL;DR

Verification & Validation Manager (MedTech): Directing teams and processes for product verification and software validation testing for digital surgery systems with an accent on regulatory compliance (FDA/EU) and quality standards. Focus on developing test automation frameworks, overseeing system testing against optical and mechanical standards, and ensuring reliability through accelerated lifecycle testing.

Location: Onsite in Goleta, California, United States

Company

hirify.global is a global leader in infusion therapy and pain management, dedicated to improving healthcare safety and lowering costs through its Sharing Expertise® philosophy.

What you will do

• Lead and manage the V&V engineering group, defining goals and tracking progress for team members.
• Develop test cases, protocols, and plans for hardware and software, ensuring alignment with product requirements.
• Oversee external testing for safety (IEC-60601-1), wireless, shipping, and EMC.
• Implement V&V best practices in compliance with FDA and EU medical device regulations.
• Establish a test automation framework to enable early defect detection and reduce manual effort.
• Collaborate with project managers to ensure milestones are met on time and within budget.

Requirements

• 8-10 years of experience in medical device development (or 5-7 years with a Master's degree).
• Minimum of 2 years of experience supervising technical staff.
• Deep understanding of medical device regulations (FDA and EU).
• Must be based in or able to work onsite in Goleta, California, United States.
• Strong skills in technical documentation and communication.

Nice to have

• Knowledge of IEC-60601-1, IEC-14971, and IEC-62304.
• Experience in the operating room (OR) supporting live surgeries.
• Background in software test automation and basic image processing.
• Familiarity with various medical imaging modes (X-ray, CT, MRI, OCT).
• Experience working with Scrum/Agile.

Culture & Benefits

• Comprehensive healthcare benefits package.
• 401(k) retirement plan.
• Tuition reimbursement for ongoing education.
• Culture based on the "Sharing Expertise®" philosophy.
• Commitment to equal opportunity and workplace diversity.