SaMD Systems Engineer

.SaMD Systems Engineer | Remote | Contract
Our client is a leading medical device organization focused on advancing innovative software-enabled healthcare solutions. They are looking to hire a SaMD Systems Engineer on a contract basis. This position is fully remote and offers the opportunity to work on highly regulated medical device products that directly impact patient care.
If you're passionate about bridging systems engineering, quality, and regulatory compliance within the medical device industry, this is an exceptional opportunity. The team is seeking an experienced professional who can quickly assess, improve, and strengthen critical product documentation while ensuring compliance with FDA and international standards. You'll play a key role in helping teams achieve audit readiness, improve traceability, and support product development efforts in a fast-paced, collaborative environment. This engagement offers exposure to cross-functional stakeholders, high-visibility projects, and the chance to make an immediate impact on regulated medical technologies.
Contract Duration: 3-4 Months Required Skills & Experience
Bachelor's degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Software Engineering, or related technical discipline
5+ years of experience in medical devices, SaMD, systems engineering, quality engineering, or regulatory documentation
Hands-on experience authoring, reviewing, and remediating medical device quality and design documentation
Strong knowledge of ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR Part 820, and EU MDR requirements
Experience with Design Controls, Verification & Validation (V&V), and requirements traceability
Strong technical writing and documentation skills
Experience with requirements and document management tools such as Jama, Polarion, DOORS, MasterControl, or Greenlight Guru
Ability to work independently and collaborate across engineering, quality, and regulatory teams
Desired Skills & Experience
Experience supporting FDA 510(k), De Novo, PMA, or EU MDR submissions
Prior participation in FDA inspections, notified body audits, or internal quality audits
Experience with connected medical devices and cybersecurity documentation requirements
Familiarity with Agile software development practices in a regulated environment
Previous consulting experience supporting multiple projects simultaneously
RAC, CQE, ASQ, or other relevant industry certifications
Experience developing SOPs, work instructions, and process documentation What You Will Be Doing
Tech Breakdown
Medical Device Software (SaMD) Documentation
Systems Engineering & Requirements Management
Design Controls & Traceability
Risk Management (ISO 14971)
Software Lifecycle Processes (IEC 62304)
FDA & EU MDR Regulatory Compliance
Verification & Validation Documentation
Daily Responsibilities
Author, review, and maintain system requirements, architecture documents, 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 You will receive the following benefits:
Medical Insurance - Four medical plans to choose from for you and your family
Dental & Orthodontia Benefits
Vision Benefits
Health Savings Account (HSA)
Health and Dependent Care Flexible Spending Accounts
Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
Hospital Indemnity Insurance
401(k) including match with pre and post-tax options
Paid Sick Time Leave
Legal and Identity Protection Plans
Pre-tax Commuter Benefit
529 College Saver Plan
Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy. Applicants need to make their needs known in advance.