Focus Area Lead - Regulated Products

Job Description

Job DescriptionFocus Area Lead – Regulated ProductsCompany Overview

Triton Systems combines over 30 years of innovation with a mission to solve complex challenges across defense, aerospace, energy, human health, and environmental markets. We develop and scale advanced technologies through a unique combination of R&D excellence and entrepreneurial execution. Our teams thrive in a collaborative, fast-paced environment where we tackle complex challenges, meet our customers' toughest requirements, and deliver high-impact results-on time, on budget and having fun while doing it.

The Health & Human Performance (HHP) group at Triton applies a human-centered approach to develop products that help people perform challenging jobs in extreme environments. Our portfolio includes both medical and non-medical technologies. The Regulated Products Focus Area centers on medical solutions such as physiological monitoring, advanced wearables, trauma care tools, and field diagnostics.

Position Summary

We are seeking a seasoned and visionary Focus Area Lead to direct multidisciplinary teams in the development of regulated medical products from concept through commercialization. This individual will provide strategic and technical leadership, ensuring product innovation aligns with user needs, regulatory requirements, and business goals.

Key Responsibilities

• Lead and mentor a cross-functional team of engineers, scientists, and designers in the development of FDA-regulated products.
• Provide technical direction across multiple projects (typically 2–4 concurrently), guiding the team through design decisions and development milestones.
• Deliver innovative solutions to complex human health and performance challenges.
• Manage program execution, ensuring timely, high-quality deliverables and customer satisfaction.
• Present results and technical content to clients and stakeholders, both orally and in writing.
• Identify and engage vendors and manufacturing partners for product transition and scale-up.
• Support business development through proposal authorship, partner engagement, and relationship building.
• Collaborate with internal teams and external partners across disciplines and industries.

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biochemistry, or a related field (Master's or PhD preferred).
• 12+ years of experience in human-centered product development, medical device innovation, or related fields.
• Proven track record leading multidisciplinary technical teams (4–6 members).
• Strong understanding of the FDA regulatory environment, including design controls, QMS, and GLP/GMP requirements.
• Demonstrated ability to manage multiple complex projects simultaneously.
• Excellent verbal and written communication skills.
• Experience with government-funded R&D, including SBIR/STTR or DoD/NIH programs, is highly desirable.
• Familiarity with engineering fundamentals and tools such as numerical analysis, modeling, or simulation.
• S. citizenship required due to the nature of our work; security clearance eligibility may be necessary.

Why Triton

• Competitive salary and full benefits package
• Opportunity to work on cutting-edge innovations with real-world impact
• A collaborative, mission-driven culture where your ideas matter
• Growth pathways through technical leadership or commercialization efforts

Join us at Triton and help shape the future of human-centered innovation. Triton Systems is proud to be an Equal Opportunity Employer – M/F/D/V/EEO.

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