Principal Systems Engineer

Digital Health Solutions; Andover (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Vision

Dental

Paid time off

Job summary

Digital Health Solutions is seeking a Principal Systems Engineer to lead system engineering, requirements management and risk management for medical device programs, with deep knowledge of IEC 62304 and ISO 13485.

You will translate customer needs into system requirements, drive verification and validation, coordinate cross‑functional teams (software, hardware, QA, regulatory), and guide design reviews to ensure compliant, safe products.

Qualifications

• Bachelors degree in engineering; advanced degree preferred.
• 10+ years of systems engineering experience in medical devices.
• Strong knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR 820.30, FDA cybersecurity guidance.

Responsibilities

• Translates voice of customer into system requirements and leads requirements development.
• Drives verification and validation activities across hardware and software.
• Coordinates with QA, regulatory affairs, design teams to ensure design controls and a compliant product.

Skills

Risk management

Regulatory knowledge

Communication

Problem solving

Education

Bachelors degree in engineering

Advanced degree preferred

Job description

Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.

We are currently seeking a talented Principal Systems Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management and risk management, as well as a deep understanding of the medical device industry.

Responsibilities

• Translates voice of customer into user needs for medical device products.
• Develops system and subsystem requirements.
• Participates in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
• Participates in safety and cybersecurity risk analysis activities.
• Ensures the requirements may be verified in compliance with design controls and other QMS SOPs.
• Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.
• Perform sprint planning and lead development activities of firmware and software developers including for Software Development Life Cycle deliverables per IEC 62304
• Reviews and develops technical documentation to ensure the planned activities match the system and subsystem verification and validation approach.
• Leads requirements verification and validation activities by actively engaging in the technical work, supervising V&V engineers as needed.
• Leads and reviews reports from external testing including 60601, biocompatibility, FCC, usability, and cybersecurity
• Participates in Design Reviews and leads technical reviews
• Coordinates and presents technical data, analyses, and status at reviews (internal and external).
• Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.
• Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with DHS senior leadership
• Stay current with industry trends, emerging threats, and best practices in medical devices to continuously improve our services and maintain our competitive edge.
• Performs other tasks as required.

Qualifications

• Bachelor's degree in engineering discipline; advanced degree preferred.
• 10+ years of experience in systems engineering, with a focus on medical devices.
• Strong knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR 820.30, ANSI/AAMI SW96, FDA Guidance for Cybersecurity in Medical Devices and other relevant medical device regulations and standards.
• Demonstrated experience in conducting risk assessments and developing risk mitigation strategies for complex systems. Knowledge of security risk management activities preferred.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.

What We Offer

• Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
• Opportunity to work with cutting-edge technology in the medical device industry.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.