Electrical/Biomedical Engineer (Entry Level)

About the role

We are seeking a Junior Electrical Engineer or Biomedical Engineer to support sustaining engineering activities for FDA-regulated medical devices. This role is ideal for an early-career engineer who has gained exposure to medical device Quality Management Systems (QMS), design controls, engineering documentation, and product change processes through internships, co-ops, or industry experience. The ideal candidate understands how engineering changes are evaluated, documented, reviewed, and implemented within a regulated environment. They are comfortable working through technical documentation, root cause investigations, design changes, and quality system processes while collaborating with quality, manufacturing, regulatory, and engineering teams.

Responsibilities

• Support engineering change activities for released medical devices, including documentation, reviews, approvals, and implementation within the Quality Management System.
• Participate in Change Control processes related to component changes, end-of-life parts, supplier changes, manufacturing improvements, and product updates.
• Assist with root cause investigations for product failures, field issues, nonconformances, and manufacturing concerns.
• Support Design Transfer activities between engineering and manufacturing teams.
• Create, review, and maintain engineering documentation including change requests, engineering change orders, test reports, risk assessments, specifications, and labeling updates.
• Work with contract manufacturers and cross-functional teams to evaluate and implement product improvements.
• Support design verification activities and testing related to product modifications.
• Update electrical schematics, BOMs, drawings, and documentation as part of approved engineering changes.
• Ensure all activities comply with established design controls and regulatory requirements.

Requirements

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, or related engineering discipline.
• Experience working within a Quality Management System through internships, co-ops, research projects, or industry experience.
• Understanding of engineering documentation and change management processes in a regulated environment.
• Exposure to medical device development, manufacturing, sustaining engineering, or quality engineering.
• Strong technical documentation and organizational skills.
• Ability to investigate technical issues and support root cause analysis activities.
• Strong communication skills and ability to work across engineering, quality, manufacturing, and regulatory teams.

Qualifications

• Internship or professional experience in the medical device industry