Full-Time
Principal System Engineer
Full Spectrum
51-200 employees
Medical device software development and testing
Compensation Overview
$150k - $205k/yr
Westborough, MA, USA
Hybrid
Hybrid: some on-site days in Westborough, Massachusetts.
Bachelor's
 Biology & Biotech (1) |
|---|
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- Bachelor’s degree in Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related science discipline
- Minimum of 8 years of relevant experience in Systems Engineering
- Proven track record in medical device development, identifying project risks, and communicating clearly with stakeholders
- Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration
- Lead and delegate by managing project execution by aligning client needs with team tasks and deliverables
- Consult and partner with Regulatory Affairs to define system intent, launch strategies, and regulatory pathways
- Mentor and coach by providing real-time guidance, training, and problem-solving for engineers, particularly within Software Test and documentation realms
- Process innovation by consulting with Test Process owners to refine methodologies while minimizing audit exposure
- Technical architecture and risk management by ensuring Safety and Security by Design for complex systems
- Safety risk analysis by leading planning for complex software-driven medical devices, performing hazard and harm assessments with clinical tam or medical director, and conducting bottom-up failure analysis (FMEA)
- Cybersecurity strategy by driving threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting to ensure FDA compliance
- Lifecycle risk management by applying risk management throughout product lifecycle using design and process risk models from ISO 14971
- V&V strategy and regulatory mastery by establishing robust V&V strategies within iterative development
- V&V leadership by overseeing system and software V&V approaches, test planning, design, and creating comprehensive test cases
- Testing strategy by implementing lifecycle-based testing per IEC 62304, from unit to system-level GUI testing
- System verification by defining and overseeing system integration, performance tests, and coordinating testing milestones
- Standard compliance by acting as subject matter expert on IEC 62304, ISO 14971, TIR-32, TIR-45, TIR 80001, IEC 81001-5-1, IEC 60601-1, IEC 60601-1-8, 21 CFR Part 820, IEC 13485, ISPE GAMP-5, IEC 62366
- Scripting in Python or C/C++, code inspection, and Object-Oriented Programming
- Experience with Machine Learning systems, algorithm management, and real-time/embedded programming
- Familiarity with Agile, version control, and automating compliant CI/CD pipelines
Full Spectrum Software (FSS) provides end-to-end software development and testing services for highly regulated industries, including Medical Devices, Life Sciences, Digital Health, Robotics, IoT, and AI. It builds and tests software and systems, guiding products from concept to deployment, with a focus on thorough documentation, regulatory alignment, and project ownership from start to finish. The company leverages ISO 13485:2016, FDA-related processes, and a track record of delivering more than 450 commercial products on time and within budget, making it a trusted partner for clients requiring compliant, dependable software. Its differentiators include deep expertise in regulated domains, proven delivery reliability, and a history of pioneering AI solutions and IoT connectivity. The overarching goal is to help customers bring safe, compliant digital health and device software to market by providing complete lifecycle software development and validation services.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Southborough, Massachusetts
Founded
1996
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Simplify's Take
What believers are saying
- July 29, 2026 growth hit 50 percent, with 12 new clients added.
- The Westborough move expands hiring capacity and supports continued 2026 expansion.
- July 9, 2025 cybersecurity services broaden the stack as device-security demand intensifies.
What critics are saying
- Customer concentration risk persists; one large account can dominate utilization and cash flow.
- Robotics and medtech hiring exposes revenue to certification delays and program cancellations.
- A failed quality incident on a regulated program would crater trust and trigger FDA scrutiny.
What makes Full Spectrum unique
- ISO 13485-certified since 2009 anchors Full Spectrum's regulated medical-device credibility.
- Full Spectrum spans medical devices, digital health, robotics, IoT, and AI under one roof.
- The firm owns end-to-end delivery, from concept through testing and FDA submission support.
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Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↓ -3%2 year growth
↓ -3%Full Spectrum achieves 50 percent growth, expands client portfolio, and moves to new headquarters. WESTBOROUGH, Mass.-(BUSINESS WIRE)-#healthcare - Full Spectrum, a rapidly growing product development and consulting company specializing in the medical device, digital health, and life science industries, today announces significant growth and expansion at the mid-year mark, with the organization growing by 50 percent compared to this time last year, the addition of 12 new clients, and the strengthening of existing customer relationships. To support its continued momentum, the company has moved to larger office space to accommodate its growing team and future expansion. Full Spectrum experienced strong demand for its services between June 2025 and June 2026, successfully onboarding a dozen new clients in the neurology, medical imaging, cardiology, and drug delivery spaces. Over this time, the company also expanded the scope of work and strategic partnerships with many long-standing customers. "I've been reflecting on the amazing journey Full Spectrum has been on over the last 12 months," said Adam Hesse, Full Spectrum CEO. "But even more important than our growth as an organization is our impact on health and well-being worldwide by helping our clients deliver life changing therapies to patients who need them. This is our mission as an organization, and the success over the last year has allowed us to realize that mission." Full Spectrum's new office space, located at 1500 W Park Drive, Suite 200, Westborough, Mass., 01581, provides expanded capacity for collaboration, innovation, and future hiring initiatives. The move represents another milestone in the company's long-term growth strategy and commitment to serving clients at the highest level. About Full Spectrum Full Spectrum helps MedTech innovators bring complex products to market faster and with greater confidence. Through its Full Spectrum Assured commitment, the company combines deep expertise in software, systems engineering, product development, and technology consulting with clear communication, disciplined execution, and accountability for outcomes. For more than 40 years, Full Spectrum has partnered with medical device, digital health, and life sciences companies to reduce risk, accelerate innovation, and deliver solutions engineered for real-world performance. Learn more at https://fullspectrumsoftware.com/.
Adam Hesse, CEO, at Full SpectrumThe emerging technologies hype cycle had multiple AI applications at the peak of inflated expectations in 2023 and were just beginning the ride down to the Trough of Disillusionment in 20241 2. For years, it’s been said that “the use of data and algorithms is going to transform healthcare.” While true to a degree, we see that MedTech companies that invest in trends like artificial neural networks, analytics, big data analytics, and now AI, often struggle to yield a significant return on investment. These technologies are undoubtedly valuable, but why do so many organizations fail to capitalize? RD dollars are precious and represent the fuel for your organization’s future growth. AI without a clear business model and an understanding of the implementation and management costs is likely to be an expensive program that fails to live up to expectations. Assessing the full impact of any new technology is an imprecise exercise, and delaying participation in the next “gold rush” could leave your business lagging behind competitors. However, spending potentially millions of dollars without a return is a larger risk. A few common mistake patterns include:New Technology Indulgence – Attempting to apply a new technology in too many places, missing a focused strategy.Guess and Launch – Informally evolving a proof of concept into a formal product that’s challenging to control.Lacking Data Management – In AI, data has a lifecycle, just like software code. The infrastructure to support it is required to be efficient and compliant. No Financial Model – Not having a defined connection between your AI initiative and your PL.Below are some key steps to help maximize the impact of limited RD funds, seize market opportunities, and maintain organizational focus, ultimately increasing the chances of AI successfully transforming your business.Focus on a ProblemBegin with the unresolved problems your customers already face—many of which you likely know
Chilean digital debt collection startup Colektia secured $9 million in funding led by Mouro Capital, with participation from Endeavor’s Forward Fund, Full Spectrum Capital, Anteris, and angel investors. Founded in 2018, Colektia aims to impact over 30 million clients by 2025 using AI and automated technologies. The company has managed over 15 million accounts and $1.6 billion in debt, achieving a CAGR of over 170% and positive net income in 2023.