Spectranetics

Senior Systems V&V Engineer

Spectranetics$133K — $212K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in systems testing, verification & validation, or systems engineering, preferably in the medical device industry.
  • Experience leading the definition and execution of system-level test strategies for complex products, including automated testing.
  • Familiarity with medical device regulatory standards (ISO 14971, IEC 62304, IEC 62366, FDA GMP/QSR).
  • Bachelor's Degree required; Master's Degree preferred in relevant engineering fields.
  • Strong communication, analytical, and problem-solving skills.

Responsibilities

  • Own the overall system-level test strategy and execution for Verification & Validation throughout the product lifecycle.
  • Translate user needs into comprehensive verification and validation activities covering various testing aspects.
  • Lead system integration testing and verification, ensuring full coverage of hardware, software, and interfaces.
  • Promote testability considerations into system architecture and design in collaboration with cross-functional teams.
  • Provide technical leadership for regulatory submissions and audits, demonstrating compliance and effective risk control.

Benefits

  • Generous PTO policy to promote work-life balance.
  • 401k plan with up to 7% company matching for retirement savings.
  • Health Savings Account (HSA) with company contributions.
  • Stock purchase plan to encourage investment in the company's future.
  • Education reimbursement to support professional development and continuous learning.
Full Job Description
Job Title
Senior Systems V&V Engineer

Job Description

Senior Systems V&V Engineer

The Senior Systems V&V Engineer is responsible for defining, owning, and executing the overall system-level Verification & Validation (V&V) strategy to ensure delivery of high-quality, safe, and compliant products that meet user, clinical, and business requirements. This role provides technical leadership for end-to-end system verification across the full product lifecycle, with strong accountability for test strategy, integration verification, and regulatory compliance.

Your role:
  • Overall ownership of system-level test strategy and execution (Verification & Validation) across the full product lifecycle, ensuring quality, compliance, and fitness for intended use. Define and maintain the System V&V Master Plan, including test approach, levels of test, environments, independence, and acceptance criteria.
  • Translate user needs and system requirements into comprehensive system-level verification and validation activities, including functional, performance, usability, safety, cybersecurity, and interoperability testing. Ensure end-to-end traceability between user needs, system requirements, risk controls, verification, and validation evidence.
  • Lead system integration testing and verification activities, ensuring proper coverage across hardware, software, subsystems, and external interfaces. Drive testability considerations upstream into system architecture and design in close collaboration with Systems Engineering, Software, Hardware, Clinical, and Quality teams. Lead and participate in technical, design, and phase-gate reviews with clear focus on verification completeness, residual risks, and release readiness.
  • Ensure system-level verification and validation supports Product Safety Risk Management and demonstrates effectiveness of risk controls in a regulation-compliant manner. Provide technical leadership and mentorship on system test practices, standards, and continuous improvement across projects and teams.
  • Act as a key partner in regulatory submissions, audits, and inspections by providing clear, defendable test strategies and objective evidence.


You're the right fit if:
  • You've acquired 5+ years of relevant experience in systems testing, verification & validation, or systems engineering with significant responsibility at the system or product level, medical device industry strongly preferred. You also possess experience with technical leadership in defining and executing system-level test strategies for complex, multi-disciplinary products and automated testing, requirements management, and digital traceability tools is strongly preferred.
  • Your skills include medical device standards and regulations, such as ISO 14971, IEC 62304, IEC 62366, FDA GMP/QSR, and related verification & validation expectations as well as managing complexity, driving results, and influencing cross-functional stakeholders in the interest of patient safety, quality, and compliance.
  • You have a Bachelor's Degree, required and Master's Degree, preferred in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • You're an excellent communicator with strong analytical and problem-solving skills, and the ability to clearly articulate verification rationale, coverage, and risk-based decisions.


How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role.

The pay range for this position in Malvern, PA is $133,000 to $212,000

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Malvern, PA.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

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