Job Title: Principal Systems Engineer – Medical Devices
Location: Thane, Maharashtra

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 protected 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
· Parti

📌 Principal Systems Engineer (Thane)
🏢 Digital Health Solutions
📍 Thane