Overview
Skills
Job Details
Resourcesys is a highly recognized provider of professional IT Consulting services in the US.
Here is our open requirement which can be filled immediately. Kindly respond to this requirement with your consultant resume, contact and current location info to speed up the interview process.
Role: Sr System Engineer
Location: Pittsburg, PA Onsite
Duration: Full Time / Contract
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 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
Typically required:
- Master's degree or equivalent in Engineering and/or business discipline or alike experience
Thanks
Varun Aanand
10294 A Baltimore National Park, Ellicott City, MD - 21042 | Ellicott City, MD
(m) || Email: