Focus Area Lead â Regulated Products
Focus Area Lead â Regulated Products
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Company 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 24 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
- Bachelors degree in Mechanical Engineering Electrical Engineering Biomedical Engineering Biochemistry or a related field (Masters 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 (46 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.
Employment Type
Full-Time
