Medical Device Risk Management Consultant

SGS_JOB_1045

Engineering
Remote
RM SME position
experience with ISO14971:2019 is necessary
Working knowledge of ISO14971:2019
MDR requirements
and IEC62366-1:2015

Contract - 12 Months+

This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.

Job Responsibilities:

  • To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:
  • Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
  • Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.
  • Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
  • Leads development and implementation of key performance indicators and metrics for the risk management process.
  • Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.

Skills:

  • RM SME position, experience with ISO14971:2019 is necessary. Risk management experience should not be before 2020. They also need to know how to apply statistics beyond process capability and SPC charts.
  • Risk Management SME
  • Must have working knowledge of ISO14971:2019, MDR requirements, and IEC62366-1:2015.
  • Must have experience in remediating risk management files for EU MDR.
  • Statistical knowledge and familiarity with Minitab are a plus.
  • Must have strong communication skills.
  • Must be able to work normal business hours.

Education/Experience:

  • Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
  • 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
  • Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).
  • Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.

Related Jobs

AI Engineer – Model Training & Finetuning

Engineering
Remote
12 Months

Location (mandatory): Remote Client is seeking a strong AI Engineer to join our AI Research team; an organization focused on making research breakthroughs in AI. Join the core team defining the future of multimodal AI. You will build the data engines and evaluation platforms that power our frontier multimodal LLMs, transforming raw data into high-fidelity benchmarks that drive breakthroughs at Client-scale. You’ll ship high-fidelity reproducible breakthroughs and bridge frontier research into Client's product ecosystem to impact billions. You'll collaborate within an interdisciplinary group of scientists and engineers, leveraging world-class compute, data resources, and research facilities.

AI
ML
LLM
Fine-tuning (SFT/preference)
Multimodal
Python
Pytorch

CX Data Scientist

Engineering
Remote
12 Months

Location (mandatory): Remote As a CX Analyst for Reality Labs’ Customer Experience (CX) team, you will join a global team leveraging customer feedback to drive service improvements and business growth. You will analyze support surveys and operational data to identify improvement areas and partner with cross-functional teams to implement enhancement strategies. By applying your expertise in data analysis and storytelling, you will help define the future of our customer support program.

CX Analytics
SQL
Python
NLP

WordPress Web Developer

Engineering
Remote
6 Months

Location (mandatory): Remote We're seeking experience a software engineering with a background in building web apps with 3+ years of experience in Python to help us build the next generation of computer-use agents. Your role will be to grow our app simulation pipeline for training and evaluating computer-use agents. You'll be contributing to the frontiers of AI agent research.

WordPress
PHP
Javascript
VIP

HR Assistant

Engineering
 Ohio
12 Months

Location (mandatory): Oxford, OH With your passion for people, you’ll partner with the plant staff including Production Supervisors, Union Stewards, and Hourly employees as appropriate, to drive plant engagement and provide excellent customer service to plant personnel. We’ll lean on you to leverage your attention to detail and multitasking skills to produce daily and weekly scheduling, process and manage timecards, metric reporting and more!

HR
Documentation
Excel
Employee Relationship.

Electrical test Technician

Engineering
 Oregon
6 Months

Location (mandatory): Tualatin, OR Work safely in a restricted access Testing Lab, performing visual inspection and product testing following standard operating procedures. Environment is a Lean one-piece flow, testing various client’s products at 208V-690V, using electronic equipment i.e., Variac, Hi-Pot/Ground Bond, Power Analyzer, Oscilloscopes, Current Clamps, Digital Multi-Meters, etc., to ensure product quality. Test and document output results of products to validate results within specifications pass range or troubleshooting of failed testing. Personal commitment to injury free operations while adhering to client’s safety protocols

Electrical Testing
High Voltage Testing

Compensation Project Manager

Engineering
 Massachusetts
80-90/Hr. on W2
3 Years

Location : Lexington, MA Reporting to the Compensation Manager, the Compensation Specialist will lead and execute critical compensation projects on a contract basis. This role is ideal for a seasoned professional with deep expertise in total rewards, job architecture, and pay structure design, who thrives in a fast-paced, project-oriented environment. • Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. • Reviews status of projects and budgets, manages schedules, and prepares status reports. • Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. • Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, clients, and other stakeholders.

Project Management
Compensation
Radford/AON
Mercer
Pearl Meyer
TSG
CCP

Brand Marketing Project Coordinator

Engineering
 Tennessee
12 Months

Location (mandatory): Franklin, TN Handle all brand campaign across all business units and services. Brand Reputation as a whole. This person will execute a multichannel brand campaign. A whole new brand is being pushed out after years of the older brand. They will create work with media, internal, materials for US related brands. This person will manage timelines, agency assets for this, internal partnering of paid, earned, and owned media for this work. Execution of actions & operations is the work. It is not building brand or material or being the market campaign designer. Campaign intake and alignment. Help determine end scope channels, what agencies and responsibilities of each, and set that for the manager. Plot clear timelines across these actions. Project management work will be using air table.

Project Management
Multichannel Marketing
Public Relations

SQL Developer

Engineering
 Washington
75-80
05 Months

Location (mandatory): Seattle, WA We are seeking a SME SQL Developer Contractor to join a high-profile project. In this role, you will be responsible for improving the performance and efficiency of our databases for our WAVE Tactical Push to Talk on premise solution. We need an expert who understands "bare metal." You will be responsible for improving high-performance database objects, maintaining transaction volumes and ensuring that our high availability solution is optimised and documented. You will be an integral part of an Agile team, supporting the full product development lifecycle. This includes preparing functional and design specifications, overseeing the development process, and handing off deliverables to the Quality Assurance Team. You will be accountable for your individual deliverables during Sprints and will collaborate directly with management, other developers, and cross-functional technical teams to manage release expectations and ensure specifications are met.

SQL
T-SQL
UDFs
triggers

Electronics Technician

Engineering
 Texas
02 Months

Location (mandatory): Allen, TX The Electronic Technician will be working in an electronics manufacturing environment diagnosing and testing Digital Video Recorder Systems and peripherals. This position will require proven ability to work from schematics, drawings, inspection reports, engineering documents and any instructions (oral or written) from the supervisor.

PCB
Electrical Testing
Repair
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


© 2026 All rights reserved.
logologologologo