Location
Pennsylvania | United States
Job description
Our client is looking Sr System Engineer for Fulltime / Contract project in Pittsburg, PA (Onsite) below is the detailed requirements.
Job Title : Sr. System Engineer
Location : Pittsburg, PA (Onsite)
Duration : Fulltime / Contract
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.
Job description:
- Master's degree or equivalent in Engineering and/or business discipline or alike experience with minimum 8+ Years of relevant experience.
- 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
- Demonstrate excellent communication skills including the ability to effectively communicate with internal and external customers.
- Ability to use strong industry knowledge to relate to customer needs and dissolve customer concerns and high level of focus and attention to detail.
Job tags
Salary
