. 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.