Sr Systems Engineer - Pittsburgh, United States - Intellectt Inc

Description

Title: Sr. Systems Engineer

Location: Pittsburg, PA

Job Description:

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 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

Typically required:

 Master's degree or equivalent in Engineering and/or business discipline or alike experience