SaMD Design Quality & Compliance Engineer

SaMD Design Quality & Compliance Engineer

Full-Time 90000 - 110000 $ / year (est.) On-site
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At a Glance

  • Tasks: Ensure software design meets global medical device standards and implement key regulations.
  • Company: Heidi, a leader in healthcare AI innovation.
  • Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
  • Other info: Collaborative environment with a focus on agile methodologies.
  • Why this job: Join a mission-driven team making a real difference in healthcare technology.
  • Qualifications: Experience in design quality and compliance within the medical device industry.

The predicted salary is between 90000 - 110000 $ per year.

Heidi is building world‑class healthcare AI with a regulatory‑savvy Design Quality & Compliance Engineer.

You will integrate with Legal & Regulatory Affairs and Engineering to ensure software design aligns with global medical device standards.

You’ll implement IEC 62304, ISO 14971, ISO 13485 within an agile context, shaping how design inputs, verification, validation and risk controls are captured and evidenced.

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SaMD Design Quality & Compliance Engineer employer: Heidi Health Corp.

At Heidi, we are not just building AI solutions; we are revolutionising healthcare with a mission that resonates deeply with our team. Our culture prioritises real-world impact, offering generous benefits like a $1,000 annual learning budget, extensive parental leave, and a focus on mental health, all while empowering you to shape the future of healthcare alongside passionate colleagues. Join us in a dynamic environment where your contributions directly enhance clinician-patient connections and where your growth is as important as our mission.

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Contact Details:

Heidi Health Corp. Recruitment Team

We think you need these skills to ace SaMD Design Quality & Compliance Engineer

Regulatory Knowledge
IEC 62304
ISO 14971
ISO 13485
Agile Methodologies
Design Inputs Management
Verification and Validation