USA Sr. Principal Engineer

Raleigh, WV - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms

Overview

This role focuses on developing and sustaining software for Infusion Pump medical devices delivering high-quality healthcare solutions that meet regulatory standards. You will lead system-level software engineering activities guide cross-functional teams and ensure compliance with medical device development processes.

Key Responsibilities

Lead best practices for software systems development and lifecycle management.
Provide technical leadership mentorship and review of engineering work.
Develop solutions for complex software system challenges under tight timelines.
Translate user needs (Clinical/Commercial) into system-level requirements.
Decompose system requirements into software subsystem requirements.
Lead software-related risk analysis (hazards mitigations).
Define verification & validation strategies using requirements traceability.
Participate in software design reviews.
Support Agile planning: estimation scheduling backlog maintenance.
Drive collaboration with internal and external stakeholders.
Ensure compliance with quality systems and design control.
Support design transfer to manufacturing service customer training.

Top Skills & Must-Haves

10 years Engineering experience (Systems or Software Engineering).
Strong systems engineering background (requirements architecture decomposition).
Experience with electro-mechanical devices (highly preferred).
Hands-on medical device / regulated industry experience (preferably FDA 21 CFR 820 ISO 13485).
Experience in Agile development backlog creation/management.
Expertise in risk management (FMEA hazard analysis risk controls).
Strong verification & validation planning test strategies traceability.
Excellent documentation communication cross-functional leadership.
Experience supporting design transfer manufacturing & service functions.

Preferred Experience

Infusion pumps drug delivery systems or other Class II/III medical devices.
Software development background (embedded software digital health apps).
Working with cross-functional teams: clinical commercial regulatory QA.

Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms Overview This role focuses on developing and sustaining software for Infusion Pump medical devices delivering high-quality healthcare solutions that meet regulatory standards. You will lead system-level...

Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms

Overview

Key Responsibilities

Lead best practices for software systems development and lifecycle management.
Provide technical leadership mentorship and review of engineering work.
Develop solutions for complex software system challenges under tight timelines.
Translate user needs (Clinical/Commercial) into system-level requirements.
Decompose system requirements into software subsystem requirements.
Lead software-related risk analysis (hazards mitigations).
Define verification & validation strategies using requirements traceability.
Participate in software design reviews.
Support Agile planning: estimation scheduling backlog maintenance.
Drive collaboration with internal and external stakeholders.
Ensure compliance with quality systems and design control.
Support design transfer to manufacturing service customer training.

Top Skills & Must-Haves

10 years Engineering experience (Systems or Software Engineering).
Strong systems engineering background (requirements architecture decomposition).
Experience with electro-mechanical devices (highly preferred).
Hands-on medical device / regulated industry experience (preferably FDA 21 CFR 820 ISO 13485).
Experience in Agile development backlog creation/management.
Expertise in risk management (FMEA hazard analysis risk controls).
Strong verification & validation planning test strategies traceability.
Excellent documentation communication cross-functional leadership.
Experience supporting design transfer manufacturing & service functions.