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Sr. Systems Engineer

4 months ago

Pittsburgh, United States Diverse Lynx Full time

Sr. Systems Engineer
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


Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.