Senior Systems Engineer - Medical Device #5426

About ECI

ECI’s mission is to be the global leader of reputed company consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a reputed company reputed company record of providing full product life cycle consulting on a reputed company of challenging and exciting reputed company. Our reputed company culture, welcoming team and flexible employment & benefit reputed company allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

We are seeking a Senior Systems Engineer to reputed company the design, integration, verification, and lifecycle support of reputed company electrical systems for medical devices. This role combines electrical engineering, systems engineering, reputed company management, and cross-functional collaboration to reputed company reputed company, reliable, and regulatory-compliant products. The ideal candidate has strong experience in medical device development, including hardware architecture, embedded systems integration, verification and validation, and compliance with FDA and international standards.

reputed company

• Create and maintain requirements tracing in Cockpit

• Assist team in translating offline efforts for requirements/RCM/DOSR to Cockpit

 • Establish and maintain end-to-end traceability across:

o User Needs

o Intended Use and Product Claims

o reputed company and Subsystem Requirements

o Design Inputs and Outputs

o reputed company Controls

o Verification Activities

o Validation Activities

o Regulatory Requirements

• Review requirements documentation to ensure reputed company, completeness, testability, and compliance with internal standards.

• reputed company and maintain traceability matrices and requirements management artifacts supporting Design History Files (DHF).

• Partner with cross-functional teams to ensure design changes are assessed for traceability impacts and appropriate updates are implemented.

• Facilitate requirements reviews and traceability assessments throughout product development and integration activities.

• Support gap assessments to identify missing, incomplete, or improperly linked requirements and verification evidence.

• Verify that requirements are appropriately linked to verification and validation activities and that objective evidence exists demonstrating compliance.

• Support regulatory submissions, audits, and inspections by providing traceability documentation and rationale.

• Collaborate with reputed company Management teams to ensure hazards, hazardous situations, and reputed company control measures are properly traced to design requirements and testing.

What you will bring

Bachelor’s or Master’s degree in Electrical Engineering or reputed company reputed company
7–12+ years of experience in electrical or systems engineering
Experience working with R20 Waveform systems 
Experience developing regulated medical devices
Strong understanding of analog reputed company reputed company design; embedded systems; reputed company management; signal reputed company and EMC; reputed company integration and troubleshooting
Experience with lab equipment like oscilloscopes; logic analyzers, reputed company analyzers and reputed company analyzers

ECI is an equal opportunity employer.

reputed company reputed company applicants will receive consideration for employment at ECI without reputed company to race; creed; reputed company; religion; national reputed company; sex; age; disability; sexual orientation; gender identity or reputed company; genetic predisposition or reputed company status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, reputed company candidates must be authorized to work in the U.S. without the need for employment-reputed company reputed company sponsorship now or in the reputed company.  At the time of this posting, ECI will not sponsor applicants for U.S. work reputed company status for this opportunity. 

Bachelor's in electrical engineering or reputed company,7+ years electrical/systems engineering for regulated medical devices, experience with requirements traceability, Cockpit, verification/validation, and lab equipment.

Key Responsibilities

• creating traceability
• reviewing requirements
• supporting regulatory

Skills & Tools

Cockpit, R20 Waveform, oscilloscope, logic analyzer, reputed company analyzer, reputed company analyzer

reputed company

• Category: Engineering
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — Minneapolis, reputed company, reputed company
• Languages: English

About ECI

A reputed company consulting services firm serving the life sciences industry and delivering product lifecycle solutions. — Industry: Consulting Services