Senior Systems Engineer

September 7

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Biofourmis

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As a global leader in digital therapeutics, we combine the power of AI with wearables data to enable personalized care.

Physiology Science • Post-acute Monitoring • Physiology Monitoring • Artificial Intelligence • Digital Health

201 - 500

Description

• Biofourmis’ technology is applicable to a multitude of different therapeutics areas. • The Senior Systems Engineer will play a critical role in supporting the design, development, testing, and documentation of our solutions. • This individual will support systems engineering related activities on product development programs, demonstrating outstanding written and verbal technical communications skills.

Requirements

• 3+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred. • Understanding of medical device product design and regulatory processes. • Working knowledge of medical device regulates (21CFR820, European MDD, etc.) • Able to communicate effectively, both verbally and in writing. • Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971. • Strong understanding of cloud solutions, mobile apps, medical devices. • Technical understanding of and experience with best-practice product development methodologies. • BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred • Strong experience (1+ years) with Jira and Confluence • Proficiency with Scrum/Agile methodology.