Sr. Verification

2 weeks ago

Carlsbad, CA, United States CARLSMED, Inc. Full time

About Carlsmed

Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.

Position Overview

The Senior V&V Engineer plays a critical role in ensuring Carlsmed's medical device software systems meet safety, performance, and regulatory requirements. This role is responsible for planning, executing, and documenting verification and validation activities across software systems. The engineer will collaborate closely with R&D, Software Engineering, Mechanical Engineering, Operations, and Regulatory teams to ensure products comply with FDA, ISO, and IEC design control standards. The ideal candidate has deep experience in software based medical device V&V, strong technical test skills, exceptional documentation discipline, and the ability to work across complex, multidisciplinary product architectures.

Key Responsibilities

Test Strategy & Planning

  • Develop and maintain comprehensive V&V plans, including Verification Plans, Validation Plans, Test Protocols, Test Reports, and Traceability Matrices.
  • Define system-level test strategies for software, hardware, and integrated platforms in compliance with FDA 21 CFR 820.30, ISO 13485, IEC 62304, etc.
  • Contribute to risk management activities (hazard analysis, FMEA) and ensure test coverage aligns with risk controls.
Execution & Documentation
  • Execute verification and validation test protocols, including functional, regression, performance, and usability testing.
  • Document objective evidence and maintain high-quality engineering records suitable for regulatory audits and submissions.
  • Ensure full traceability between user needs, system/software requirements, risk controls, and test cases.
Cross-Functional Collaboration
  • Work closely with Mechanical Engineering and Operations to clarify requirements and ensure they are testable and unambiguous.
  • Partner with Software, Clinical, and Quality teams to identify defects early and improve design robustness.
  • Support Regulatory and Quality teams by contributing to 510(k) and technical documentation packages.
Tools & Process Ownership
  • Manage test environments-including configurations for hardware, imaging datasets, and software builds.
  • Use and improve test management tools such as Jira, TestRail, Jama, etc.
  • Drive continuous improvement in V&V processes, including automation opportunities, documentation templates, and design control workflows.
System-Level Testing
  • Conduct integrated testing across imaging, planning software, and hardware subsystems.
  • Support image-based testing (CT, MRI, X-ray) and anatomical model validation as needed.
  • Perform root-cause analysis in collaboration with engineering teams for system failures or anomalies.
Qualifications
  • Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Computer Science, Mechanical Engineering, or related field.
  • 5+ years of experience in V&V for medical devices or other regulated industries.
  • Strong knowledge of FDA, ISO 13485, IEC 62304, etc. standards and Design Controls.
  • Hands-on experience writing V&V documentation (test plans, protocols, reports, trace matrices).
  • Proficiency in testing complex systems that combine software, hardware, and clinical workflows.
  • Familiarity with defect tracking and test management tools (e.g., Jira, TestRail, Jama).
  • Strong analytical, troubleshooting, and communication skills.
  • Experience with imaging-based systems, surgical workflows, or cloud-connected devices is a plus.
  • (Preferred) Background supporting regulatory submissions such as 510(k).


Equal Opportunity Employer

Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected salary range is $122,000 to $145,000. Compensation may vary based on related skills, experience, and relevant key attributes.

  • Sr. Software QA Engineer

    2 weeks ago

    Carlsbad, CA, United States CARLSMED, Inc. Full time

    Position Overview The Senior Software QA Engineer will play a key role in ensuring the quality, performance, and reliability of Carlsmed's web-based applications deployed in AWS. This position involves designing and executing comprehensive test plans, building automated test suites, and collaborating closely with software developers, DevOps, and product...

  • Sr. Software QA Engineer

    2 weeks ago

    Carlsbad, CA, United States CARLSMED, Inc. Full time

    About Carlsmed Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time. Position Overview The Senior Software QA Engineer will play a key role in ensuring the quality,...

  • Sr. Systems Test Engineer

    1 week ago

    Carlsbad, CA, United States PEAK Technical Staffing USA Full time

    What you'll do: As a member of a fast-paced Test Engineering Team within the company's Government department - Secure Network Systems, you will work with the test team to collaborate closely with the product design team. Your role involves interpreting module requirements and turning them into corresponding Qualification and Certification Test Plans,...

  • Sr. Electromechanical Manufacturing Engineer

    2 weeks ago

    Carlsbad, CA, United States Kforce Full time

    Responsibilities Kforce has a client in need of a Senior Electromechanical Manufacturing Engineer (FDA).Responsibilities: Create and implement new manufacturing processes for medical devices Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products Perform characterization studies, Design...

  • Sr. Electromechanical Manufacturing Engineer

    2 weeks ago

    Carlsbad, CA, United States Kforce Full time

    Responsibilities Kforce has a client in need of a Senior Electromechanical Manufacturing Engineer (FDA).Responsibilities: Create and implement new manufacturing processes for medical devices Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products Perform characterization studies, Design...

  • Sr. Electromechanical Manufacturing Engineer

    1 week ago

    Carlsbad, CA, United States Kforce Full time

    Responsibilities Kforce has a client in need of a Senior Electromechanical Manufacturing Engineer (FDA).Responsibilities: Create and implement new manufacturing processes for medical devices Collaborate with global suppliers to define manufacturing processes, equipment, and tools/fixtures to ensure quality products Perform characterization studies, Design...

  • Sr. Verification

    2 hours ago

    Carlsbad, United States CARLSMED, Inc. Full time

    About CarlsmedOur mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.Position OverviewThe Senior V&V Engineer plays a critical role in ensuring Carlsmed's medical device software...

  • Sr. Verification

    1 hour ago

    Carlsbad, United States Exceptional Dental Full time

    Position Overview The Senior V&V Engineer plays a critical role in ensuring Carlsmed’s medical device software systems meet safety, performance, and regulatory requirements. This role is responsible for planning, executing, and documenting verification and validation activities across software systems. The engineer will collaborate closely with R&D,...

  • Sr. and Staff Fiber Optic R&D Engineer

    2 hours ago

    Carlsbad, United States Bolt Medical Full time

    Base pay range: $140,000.00/yr - $165,000.00/yr Full-time, Mid-Senior level, Engineering and Information Technology The Sr. Fiber Optic R&D Engineer will develop and optimize optical fiber manufacturing processes for medical device applications. They will lead process development, design and develop therapeutic medical devices, support product transfer to...

  • Senior Validation Engineer — Medical Device V&V Lead

    3 weeks ago

    Carlsbad, United States ATEC Spine Full time

    A leading medical device company in Carlsbad, CA is seeking a Sr. Validation Engineer to oversee complex software verification processes. The ideal candidate will lead validation activities, define verification strategies, and ensure compliance with FDA and ISO standards. A Bachelor's or Master's degree in Biomedical Engineering and 8+ years of V&V...

  • Senior Validation Engineer

    3 weeks ago

    Carlsbad, United States ATEC Spine Full time

    The Sr. Validation Engineer is an advanced role responsible for creating, planning, and executing complex software verification activities, and contributing to continuous improvement and validation processes. The Sr. Validation Engineer collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory...

  • Senior Validation Engineer

    1 hour ago

    Carlsbad, United States Alphatec Spine Full time $130,000 - $160,000

    The Sr. Validation Engineer is an advanced role responsible for creating, planning, and executing complex software verification activities, and contributing to continuous improvement and validation processes. The Sr. Validation Engineer collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical...

  • Embedded Software Architect

    4 weeks ago

    Carlsbad, United States Acara Solutions, An Aleron Company Full time

    1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Acara Solutions, An Aleron Company Sr. Engineering Recruitment Specialist at Acara Solutions Acara Solutions is seeking an Embedded Software Architect for Mission Critical Systems to join our client on a Full Time...

  • Embedded Software Architect

    6 days ago

    Carlsbad, United States Acara Solutions, An Aleron Company Full time

    1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Acara Solutions, An Aleron Company Sr. Engineering Recruitment Specialist at Acara Solutions Acara Solutions is seeking an Embedded Software Architect for Mission Critical Systems to join our client on a Full Time...

  • Sr. Quality Engineer

    2 hours ago

    Carlsbad, United States CARLSMED, Inc. Full time

    Position DescriptionCarlsmed is seeking an experienced Senior Quality Engineer to support New Product Introduction (NPI), design transfer, product sustaining, and supplier quality activities for spine implants and instrumentation. This senior individual contributor role owns quality deliverables for design transfer and leads supplier selection,...

  • Sr. Development Engineer

    2 hours ago

    Carlsbad, United States CARLSMED, Inc. Full time

    About CarlsmedOur mission is to improve outcomes and decrease the cost of healthcare for spine surgery. The Carlsmed aprevo personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.Position DescriptionThe Senior Development Engineer designs and advances Carlsmed's patient-specific implants,...