Intellectt Inc

Systems Engineer - Medical Devices

Intellectt Inc Hopkins, MN
Intellectt Inc

Systems Engineer - Medical Devices

Intellectt Inc Hopkins, MN
1 week ago 33 applicants

See who Intellectt Inc has hired for this role

Role: Systems Engineer – Medical Devices

Location: Pittsburg, PA

Mandatory Skills

Systems Engineering for Electromechanical Medical Devices, InCose certification ISO 13485, ISO 14971, IEC 62304, Usability for Medical devices, Regulatory for Medical Devices Requirements Management, Jira, IEC 60601-1 and any Particular standards.

  • Overall technical leadership and responsible for realization of full systems product release/life cycle management to ensure quality and compliance.
  • Translation of user and business requirements into product requirements, high level product design, check and optimize integration and verification
  • System decomposition and allocation of derived requirements down to HW/SW element and part level and related traceability.
  • Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews.
  • Ensuring full Product Safety Risk Management in a regulation compliant manner KPI

Product Quality

Including but not limited to:

  • Product Performance
  • (Regulatory) Compliance
  • Product Reliability
  • Technical growth/leadership
  • Stakeholder management
  • On-time delivery to commitments

  • Seniority level

    Entry level

  • Employment type

    Contract

  • Job function

    Information Technology

  • Industries

    Medical Equipment Manufacturing and Biotechnology Research

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