Senior Systems Engineer

Company Overview

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 Senior Systems Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management and risk management, along with hands-on electrical engineering skills, including electrical component analysis with review of datasheet, board bring-up, troubleshooting, and rework / soldering. This is a multidisciplinary role requiring understanding of the design controls process for medical device industry.

Responsibilities

• Translates voice of customer into user needs for medical device products.
• Develops system and subsystem requirements.
• Works closely with multi-disciplinary engineering team, including hardware and software engineers, to design, integrate, and verify embedded systems.
• 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.
• Coordinates system verification and validation activities, including integration of mechanical, electrical, and software components.
• Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.
• 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

What We Offer