Senior SW Test & Validation Engineer

Tranzeal Incorporated; Marana (AZ); On-site; USD 150,000 - 185,000; Full time

Job summary

A leading medical device firm is looking for a strategic Product Owner – Test to lead testing strategy and campaign execution for Class III devices. The ideal candidate will possess over 10 years of experience in software testing for hardware-integrated systems, particularly in FDA-regulated environments. Responsibilities include driving the testing strategy, managing test campaigns, and collaborating with cross-functional teams. Candidates must be authorized to work in the United States. Relocation may be considered for candidates.

Qualifications

• 10+ years of experience in software testing for hardware-integrated systems.
• Medical device testing experience is required.
• Experience working in FDA-regulated environments.
• Experience in FDA-regulated environments; FAA experience a plus.

Responsibilities

• Own and drive the overall testing strategy and vision for medical device programs.
• Lead and manage test campaigns for Class III medical devices.
• Collaborate cross-functionally with engineering, quality, and regulatory teams.
• Translate customer and regulatory requirements into comprehensive testing strategies.
• Manage, build, and prioritize the test backlog in a SAFe Agile environment.
• Define user stories, acceptance criteria, and “definition of done” standards.
• Formally accept features and user stories to ensure quality and compliance.
• Collaborate cross-functionally with engineering, quality, and regulatory teams.
• Present project updates and complex technical findings to diverse stakeholder groups.
• Participate in PI planning, iteration planning, and continuous improvement events.

Skills

Experience leading test strategy and campaigns

Excellent communication skills

Stakeholder management

Regulated environments

FDA/regulatory experience

SAFe Agile

Stakeholder communication

Relocation openness

Job description

• Candidates must be authorized to work in the United States.
• Sponsorship is not available for this position.

We are seeking a strategic and experienced Product Owner – Test to lead testing strategy and campaign execution for Class III medical devices. This individual will act as the Product Owner for Test, owning the overall vision, strategy, and execution of device-level and embedded software testing efforts.

This is not a hands-on tester role. The ideal candidate is a strategic thought leader who understands complex hardware-integrated systems and can design, plan, and lead comprehensive test campaigns in a regulated environment.

Key Responsibilities

• Own and drive the overall testing strategy and vision for medical device programs
• Lead and manage test campaigns for Class III medical devices
• Plan and oversee device-level, integration, and embedded software testing
• Translate customer and regulatory requirements into comprehensive testing strategies
• Manage, build, and prioritize the test backlog in a SAFe Agile environment
• Define user stories, acceptance criteria, and “definition of done” standards
• Formally accept features and user stories to ensure quality and compliance
• Collaborate cross-functionally with engineering, quality, and regulatory teams
• Present project updates and complex technical findings to diverse stakeholder groups
• Participate in PI planning, iteration planning, and continuous improvement events

Required Qualifications

• 10+ years of experience in software testing for hardware-integrated systems
• Experience leading test strategy and campaigns (not solely hands-on execution)
• Medical device testing experience (required)
• Experience working in FDA-regulated environments (FAA experience is a plus)
• Strong understanding of:
• Integration testing
• Embedded software testing
• Experience working in a SAFe Agile environment
• Excellent communication and stakeholder management skills
• Experience in highly regulated industries (medical device strongly preferred)
• Background in strategic test planning and quality leadership
• Ability to relocate (manager open to relocation candidates)