Remote SaMD Systems Engineer for Regulated Medical Devices

Motion Recruitment Partners LLC; Franklin Township (NJ); On-site; USD 96,000 - 152,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Orthodontia Benefits

Vision Benefits

Health Savings Account

Health Spending Accounts

Life Insurance

401(k) with match

Paid Sick Time

Identity Protection Plans

Commuter Benefit

College Savings Plan

Job summary

Motion Recruitment Partners LLC is seeking a SaMD Systems Engineer for a fully remote contract role lasting 3-4 months. You will bridge systems engineering, quality, and regulatory teams to ensure audit readiness and robust medical device documentation.

Requirements include a strong background in SaMD, ISO 13485, IEC 62304, and FDA/EU regulatory standards, plus hands-on experience with design controls, V&V, and traceability. Strong writing skills and independent work capability are essential.

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• 5+ years of experience in medical devices, SaMD, or regulatory documentation.
• Authoring, reviewing, and remediating medical device quality and design documentation.
• Strong knowledge of ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR Part 820, EU MDR.
• Experience with Design Controls, Verification & Validation, and requirements traceability.
• Strong technical writing and documentation skills.
• Experience with Jama, Polarion, DOORS, MasterControl, or Greenlight Guru.
• Ability to work independently and across engineering, quality, and regulatory teams.

Responsibilities

• Author, review, and maintain system requirements, architecture, traceability matrices, and V&V documentation.
• Evaluate existing quality and engineering documentation for compliance gaps and corrective actions.
• Support Design History Files (DHF), Device Master Records (DMR), and Technical Files.
• Contribute to risk analyses, risk management files, and usability engineering documentation.
• Partner with Software Engineering, Systems Engineering, Quality, and Regulatory teams to ensure documentation accuracy.
• Support internal audits, regulatory inspections, and submission readiness activities.
• Participate in design reviews, CAPA investigations, and change control processes.
• Recommend and implement improvements to documentation processes and audit readiness efforts.
• Assist with SOP, template, and work instruction development to enhance quality system effectiveness.

Skills

Systems engineering

Regulatory documentation

Technical writing

Design Controls

V&V

Traceability

Education

Bachelor's degree in Biomedical Engineering / related field

Tools

Jama

Polarion

DOORS

MasterControl

Greenlight Guru

Job description

Motion Recruitment Partners LLC is seeking a SaMD Systems Engineer for a fully remote contract role lasting 3-4 months. You will bridge systems engineering, quality, and regulatory teams to ensure audit readiness and robust medical device documentation.

Requirements include a strong background in SaMD, ISO 13485, IEC 62304, and FDA/EU regulatory standards, plus hands-on experience with design controls, V&V, and traceability. Strong writing skills and independent work capability are essential.