Hardware Systems Engineer

Job Description

Job Description

Salary : $100,000 - $140,000 annually

Job Title : Hardware Systems Engineer Medical Devices

Genomadix Inc. is bringing rapid, portable DNA testing to the world. Our sample-to-result technology aims to bring portability and convenience to applications such as precision medicine, infectious disease, pharmacogenetics, and food and water safety testing. Rapid DNA results improve lives. We need your help to make this world a reality.

Job Description :

We are seeking a Hardware Systems Engineer to support the design, development, and lifecycle management of medical device hardware systems. This role plays a critical part in ensuring products meet performance, safety, and regulatory requirements while adhering to applicable quality standards. The ideal candidate thrives in a highly regulated environment and works collaboratively across R&D, product, quality, regulatory, and manufacturing teams.

What you'll be doing :

• Design and develop hardware system architectures for medical devices in accordance with design controls
• Define and manage system-level requirements, specifications, and interfaces
• Execute verification and validation activities to ensure compliance with product requirements
• Support risk management activities, including hazard analysis and mitigation (ISO 14971)
• Participate in design reviews, FMEA, and root cause investigations
• Support prototype builds, design transfer, and manufacturing scale-up
• Ensure compliance with applicable standards and regulations (e.g., IEC 60601, ISO 13485)
• Generate and maintain technical documentation, including design history file (DHF)
• Support post-market activities, including field issues, CAPAs, and product improvements

What you bring to the table :

Genomadix Inc. is an equal opportunity employer and is committed to an inclusive, barrier-free recruitment and selection processes and work environments. Please let us know of any accommodations needed to ensure you have access to a fair and equitable process.

Job Type : Full-time

Benefits :