Principal Systems Analysis Engineer
4 weeks ago
Principal Systems Engineer Location: Andover, MA (In-person)
Digital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU regulatory frameworks, DHS helps clients accelerate product development while ensuring patient safety and clinical impact remain at the core. Our mission is simple yet powerful: to guide the development of medical technologies that improve and save lives.
We are seeking an accomplished Principal Systems Engineer to join our growing team. This role is ideal for a highly experienced systems thinker who thrives at the intersection of engineering, clinical application, and regulatory compliance. The Principal Systems Engineer will lead complex projects across Class II and III medical devices, bringing together cross-functional teams to deliver innovative solutions in areas such as neurostimulation, cardiac support, and medical imaging.
We are looking for a candidate who combines technical depth, regulatory fluency, and leadership presence . The ideal candidate is someone who can balance innovation with compliance, build consensus across diverse stakeholders, and drive projects to successful completion in fast-paced environments.
Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.
Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
Architect system-level solutions, define interfaces, and guide trade-off analyses to achieve optimal design outcomes.
Oversee risk management activities (HA, FMEA, risk-benefit analysis) ensuring compliance with ISO 14971 and related standards.
Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams to resolve conflicts and ensure alignment.
Mentor junior engineers, fostering professional growth and building DHS’s technical leadership bench.
Contribute to program management activities including project planning, deliverable tracking, and executive reporting.
Master’s degree in Biomedical, Electrical, Systems, or related Engineering field (PhD a plus).
~10+ years of experience in systems engineering within Class II/III medical devices.
~ Strong knowledge of regulatory compliance (FDA 21 CFR Part 11/820, EU MDR, ISO 13485, IEC 60601, IEC 62304, ISO 14971).
~ Experience leading cross-functional teams, managing CAPAs, and closing complex regulatory gaps.
~ Skilled in tools such as JIRA, Confluence, and test management platforms.
~ Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
The opportunity to work on cutting-edge medical technologies that directly improve patient lives.
Exposure to a broad range of projects and modalities , from implantable devices to advanced imaging systems.
Mentorship and collaboration with leading experts in systems engineering, regulatory affairs, and product development.
-
Principal Systems Analysis Engineer
3 weeks ago
Acton, MA, United States Raytheon Full timeTewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USA Position Role Type: Citizen, U.Person, or Immigration Status Requirements: S. government issued security clearance is required prior to start date. S. citizens are eligible for a security clearance Security Clearance: Secret - Current At Raytheon, the...
-
Principal Systems Analysis Engineer
3 weeks ago
Middleton, MA, United States Raytheon Full timeTewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USA Position Role Type: Citizen, U.Person, or Immigration Status Requirements: S. government issued security clearance is required prior to start date. S. citizens are eligible for a security clearance Security Clearance: Secret - Current At Raytheon,...
-
Principal Systems Analysis Engineer
3 weeks ago
North Reading, MA, United States Raytheon Full timeTewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USA Position Role Type: Citizen, U.Person, or Immigration Status Requirements: S. government issued security clearance is required prior to start date. S. citizens are eligible for a security clearance Security Clearance: Secret - Current At Raytheon, the...
-
Principal Systems Engineer
3 weeks ago
Andover, United States Digital Health Solutions Full timePrincipal Systems EngineerLocation: Andover, MA (In-person)Company OverviewDigital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU...
-
Principal Systems Engineer
4 weeks ago
Andover, United States Digital Health Solutions Full timePrincipal Systems EngineerLocation: Andover, MA (In-person)Company OverviewDigital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU...
-
Principal Systems Engineer
9 hours ago
Andover, United States Raytheon Technologies Full timeDate Posted:2025-12-08Country:United States of AmericaLocation:MA133: Tewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USAPosition Role Type:OnsiteU.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government issued security clearance is required prior to start date. U.S....
-
Principal Systems Analysis Engineer
2 weeks ago
Tewksbury, MA, United States Raytheon Full time1 Assabet 50 Apple Hill Drive Assabet - Building 1, Tewksbury, MA, 01876 USA Citizen, U.Person, or Immigration Status Requirements: S. government issued security clearance is required prior to start date. S. citizens are eligible for a security clearance Security Clearance: At Raytheon, the foundation of everything we do is rooted in our values and...
-
Principal Logistics System Engineer
3 weeks ago
Andover, MA, United States Raytheon Full timeCitizen, U.Person, or Immigration Status Requirements: The ability to obtain and maintain a U.S. government issued security clearance is required. S. citizens are eligible for a security clearance Security Clearance: DoD Clearance: At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies...
-
Principal, Analysis/Systems Engineering
2 weeks ago
Tewksbury, MA, United States Raytheon Full timeTewksbury, Ma Bldg 3 Concord 50 Apple Hill Drive Concord - Building 3, Tewksbury, MA, 01876 USA Citizen, U.Person, or Immigration Status Requirements: S. government issued security clearance is required prior to start date. S. citizens are eligible for a security clearance Security Clearance: At Raytheon, the foundation of everything we do is...
-
Principal Logistics System Engineer
3 weeks ago
Andover, MA, United States Raytheon Full timeDate Posted: 2025-09-17 Country: United States of America Location: MA600: Andover, MA 366 Lowell St 366 Lowell Street , Andover, MA, 01810-5423 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required,...
