Systems Test Engineer - medical Devices 2d/3d Imaging
Not Disclosed•Full-TimeOn-site
location_onBig Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
About the Team
Our multidisciplinary Hardware Team is dedicated to creating innovative 2D and 3D imaging clinical solutions that make life better. As the world faces complex challenges, our purpose remains at the forefront of our mission: to deliver safe, reliable, and compliant medical devices that improve patient outcomes.
About the Role
The Lead System Test Engineer serves as a critical pillar for the San Diego System Test team, providing the technical leadership and strategic direction needed to navigate increasing complexity. This role is vital for the success of our organization as we integrate Avila Flight 3 and Trinity while managing a growing volume of sustaining activities.
In this position, you will lead system-level verification and validation for the IntraSight platform across both New Product Introduction (NPI) programs and sustaining engineering projects. You will drive the system test strategy, ensuring products meet rigorous performance, safety, quality, and regulatory requirements throughout the entire product lifecycle. From concept through release and post-market support, you will collaborate closely with internal stakeholders and external suppliers to resolve issues, manage risks, and ensure audit-ready documentation.
Hiring Process
To apply for this opportunity, please contact Abdul or email the recruiter directly using the contact information provided in the original posting.
Work location
Work model: On-site
Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
San Diego, California
Key Responsibilities
- check_circleLead system-level verification and validation activities for the IntraSight platform
- check_circleLead multidisciplinary testing teams in functional, integration, and compliance testing
- check_circleSupport sustaining activities including design changes, supplier changes, and CAPA
- check_circleLead root cause investigations and failure analysis for system-level defects
- check_circleEnsure traceability between requirements, risks, test cases, and verification evidence
- check_circleSupport regulatory submissions and audits by providing complete test documentation
- check_circleEnsure compliance with applicable medical device standards and regulations
- check_circleDrive continuous improvement of system test methodologies and automation strategies
- check_circleCollaborate with engineering, quality, and regulatory teams to ensure effective test coverage
- check_circleDrive system verification activities throughout the product development lifecycle
- check_circleDefine and execute comprehensive system test strategies, plans, protocols, and reports
Requirements
- verifiedBachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related field
- verifiedMinimum 15 years of experience leading testing teams in a medical device environment
- verifiedStrong experience in system verification and validation for complex medical device systems
- verifiedProven experience supporting New Product Introduction (NPI) and sustaining engineering activities
- verifiedDeep understanding of medical device development processes including verification, validation, risk management, and traceability
- verifiedExperience collaborating with regulatory agencies and external accredited test laboratories
- verifiedStrong knowledge of IEC 60601-1 and IEC 60601-1-2 standards
- verifiedFamiliarity with IEC 60601-2-34 and IEC 60601-2-37 standards
- verifiedExperience with system integration testing, regression testing, and reliability testing
- verifiedExperience supporting complaint investigations, CAPA, and post-market surveillance activities
- verifiedExperience working with cross-functional and global teams
- verifiedFamiliarity with requirements and test management tools (e.g., DOORS, DNG, Windchill, Jira, test automation frameworks)
Nice to Have
Familiarity with IEC 60601-2-34 and IEC 60601-2-37 standards.
Similar Job Opportunities
Skills, education and keywords
Skills: 2D Imaging, 3D Imaging, System Verification, System Validation, New Product Introduction, Sustaining Engineering, Functional Testing, Integration Testing, Regression Testing, Reliability Testing.
Education: Bachelor's in Electrical Engineering required; Master's in Electrical Engineering required; Bachelor's in Mechanical Engineering required.
Frequently asked questions about Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc.
What does a Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. do?expand_more
Day-to-day, the Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. will lead system-level verification and validation activities for the intrasight platform; lead multidisciplinary testing teams in functional, integration, and compliance testing; support sustaining activities including design changes, supplier changes, and capa; and lead root cause investigations and failure analysis for system-level defects.
What are the requirements for this Systems Test Engineer - medical Devices 2d/3d Imaging role?expand_more
To qualify for the Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. position, applicants should have: Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related field; Minimum 15 years of experience leading testing teams in a medical device environment; Strong experience in system verification and validation for complex medical device systems; Proven experience supporting New Product Introduction (NPI) and sustaining engineering activities; Deep understanding of medical device development processes including verification, validation, risk management, and traceability; and Experience collaborating with regulatory agencies and external accredited test laboratories.
Where is the Systems Test Engineer - medical Devices 2d/3d Imaging role at APN Software Services, Inc. located?expand_more
Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. is based in Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States. This is a on-site role.
Is this Systems Test Engineer - medical Devices 2d/3d Imaging job remote, hybrid, or on-site?expand_more
APN Software Services, Inc. has listed this Systems Test Engineer - medical Devices 2d/3d Imaging role as on-site.
How much experience is required for this Systems Test Engineer - medical Devices 2d/3d Imaging role?expand_more
Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. typically requires 15+ years of relevant experience at the lead level.
What skills do you need for the Systems Test Engineer - medical Devices 2d/3d Imaging role at APN Software Services, Inc.?expand_more
Key skills for Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. include 2D Imaging; 3D Imaging; System Verification; System Validation; New Product Introduction; Sustaining Engineering; Functional Testing; and Integration Testing.
What education is required for Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc.?expand_more
Educational requirements for this role: Bachelor's in Electrical Engineering required; Master's in Electrical Engineering required; and Bachelor's in Mechanical Engineering required.
What category does the Systems Test Engineer - medical Devices 2d/3d Imaging role belong to?expand_more
Systems Test Engineer - medical Devices 2d/3d Imaging at APN Software Services, Inc. is part of the engineering job category on Recrutus.
About APN Software Services, Inc.
APN Software Services, Inc. operates as a consulting organization within the IT Services and IT Consulting sector, headquartered in Newark, California. Since its incorporation in 1996, the firm has expanded its footprint across 30 states in the United States, maintaining a strategic presence in Silicon Valley. The company delivers Onsite, Offshore, and Business Process Outsourcing solutions focused on IT, Engineering, and Software development.
The organization serves a diverse range of clients through specialized practice teams. Key sectors include Networking, Medical Imaging, Retail, Financial institutions, Communications, and Pharmaceuticals. APN leverages over forty years of management experience in the technology industry to support its operations. The firm structures its delivery through dedicated business units and a strong financial platform designed to ensure consistent client experiences.
By combining experienced professionals with a global service model, APN Software Services, Inc. facilitates technology implementation and operational support for organizations requiring specialized expertise. The company maintains a focus on quality management and talent deployment to meet the evolving needs of its client base across various industries.
Browse more roles: All APN Software Services, Inc. jobs, engineering jobs on Recrutus.