Design Assurance

Location: Cupertino, California, United States
Salary: competitive
Job Type: Contract
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Currently working with a leading technology company based in the Cupertino area that is working on a ground-breaking medical device product within the wearables space. This company believes that talent is the greatest asset and resource to a company. They prides themselves on relying on the ideas of the people that serves to drive their industry leading environment. It is their trust in their people that causes them to revolutionize industries.

Would a fast paced environment make you thrive? Do you find yourself thinking of new solutions and alternatives for the way companies usually run things? Do you enjoy getting challenged and learning from the best and the brightest? Do you find yourself going against the status quo?

We are looking for passionate self-starters who are always up to be challenged. You will have the opportunity to be surrounded and inspired by brilliant and extraordinary industry leaders. You will play a key part in helping deliver the next ground-breaking medical device product.

The Ideal Candidate:

  • Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
  • Maintain current knowledge of global medical device regulations pertaining to Design Control, Product Realization, Risk Management and Reliability. Act as consultant to other departments, participate in decision-making concerning policies, requirements and strategies, and manage external consultants as needed.
  • Previous experience with Software as a Medical Device (SAMD) and previous work with embedded software
  • Manufacturing background and hardware experience
  • At least five years of experience working within life science companies (biotech, pharmaceutical, and medical device) within a design quality engineer or a software quality engineer role
  • Previous Start-Up experience preferred
  • BA/BS in Engineering, Computer Science, Biomedical, or related technical field or equivalent practical experience is ideal

Culture fit

  • A self-starter, motivated and able to positively motivate others
  • Must be a hands-on leader and practical thinker, able to identify and devise realizable solutions and roll-up sleeves to get things done.

Role: This role is an initial one year project but we are looking to convert and hire full time for the right candidate!

Sthree US is acting as an Employment Business in relation to this vacancy.

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