Job Description

Principal Systems Engineer

Location: Andover, MA (In-person)

Company Overview

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.

Position Overview

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.

At DHS, you won’t just contribute technical, you will shape strategy, mentor emerging engineers, and influence the next generation of patient-focused technology. This is a hands-on leadership role where you’ll translate clinical needs into actionable requirements, architect and validate systems, and drive design control excellence from concept through commercialization.

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.

Key Responsibilities

• Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.
• Translate user and clinical needs into system, subsystem, and component requirements while maintaining rigorous traceability.
• Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
• Ensure requirements can be verified in compliance with design controls and other QMS SOPs.
• 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.
• Direct verification and validation strategies, author test protocols/reports, and coordinate testing with external labs.
• Drive design control documentation and ensure adherence to ISO 13485, IEC 60601, IEC 62304, and FDA/EU regulations.
• 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.
• Support business development efforts through technical input to proposals, client engagement, and thought leadership.

Preferred Qualifications

• 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.
• Proven track record in requirements management, system architecture, and verification/validation.
• 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.
• Strong interpersonal skills with the ability to communicate effectively across technical and non-technical audiences.

What We Offer

• 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.
• A role where your technical leadership and strategic insight shape both client success and DHS’s growth.
• The satisfaction of delivering solutions that balance innovation, compliance, and patient safety —making a tangible impact in healthcare.

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