Systems Engineer

Role: Sr System Engineer

Location: Pittsburg, PA

EXP-7+ Years

Kindly Share suitable profile at – rahul@infinitysolutions.ca

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

Job Types: Full-time, Contract

Pay: $45.00 - $50.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Experience level:

• 7 years

Schedule:

• 8 hour shift

Ability to Relocate:

• Pittsburg, MO 65724: Relocate before starting work (Required)

Work Location: In person