2 Sr. Medical Device Systems Engineer Jobs in Addison, TX

SORT BY

SET JOB ALERT

OFF

Details...

Sr. Medical Device Systems Engineer

Katalyst Healthcares & Life Sciences

Addison, TX | Full Time

$82k-105k (estimate)

2 Days Ago

Sr. Engineer, Cloud Systems

MPOWERHealth

Addison, TX | Full Time

$110k-136k (estimate)

1 Week Ago

Sr. Medical Device Systems Engineer

$82k-105k (estimate)

Full Time 2 Days Ago

Save

Katalyst Healthcares & Life Sciences is Hiring a Sr. Medical Device Systems Engineer Near Addison, TX

Responsibilities:

Systems Design and Development: Lead the design and development of systems within medical devices, ensuring they meet performance, safety, and regulatory requirements.
Requirement Management: Define, document, and manage system requirements, ensuring alignment with customer needs, regulatory standards, and product specifications.
Risk Management: Identify and assess risks associated with the medical device system, implementing strategies to mitigate them and ensuring compliance with risk management standards.
Verification and Validation: Develop and execute verification and validation plans to ensure that the system functions as intended and complies with regulatory requirements.
Integration: Oversee the integration of various components, subsystems, and software within the medical device, ensuring seamless functionality.
Regulatory Compliance: Stay up to date with medical device regulations (e.g., FDA, ISO 13485) and ensure that the system design and development processes align with these regulations.
Collaboration: Collaborate with multidisciplinary teams, including electrical engineers, software engineers, quality assurance, and regulatory affairs professionals, to achieve project goals.
Documentation: Maintain comprehensive documentation of system design, development, and testing activities to support regulatory submissions and audits.
Problem Solving: Troubleshoot and resolve technical issues related to system design and integration, ensuring that the device meets performance standards.
Project Management: Manage project timelines, budgets, and resources effectively to ensure on-time and within-budget delivery of medical device systems.

Requirements:

Bachelor's degree in a relevant engineering discipline (e.g., biomedical engineering, electrical engineering, systems engineering)
3 years of experience in systems engineering, preferably in the medical device industry
Software Application Development Experience within a cloud environment
Design Control, CFR 820, ISO 13485
Device History File generation and maintenance
Software product development experience SDLC, 62304 standard compliances
Verification and Validation
Risk analysis, ISO 14975