Design Assurance Engineer

SGS_JOB_3002

Engineering
 Colorado
FDA Quality System Regulations
especially Design Control requirements
ISO 13485 and Medical Device Directive

Contract - 06 Months

Location : Louisville CO USA 80027 We are looking for the Design Assurance Engineer who will providing design assurance support for new product development and on market medical devices. This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts

Job Responsibilities:

  • Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
  • Participate independently in doing thorough reviews/audit of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
  • Participate independently on thorough reviews/audit Requirements Trace Matrix and assuring the trace matrix is accurate and meeting design control requirements for medical devices.
  • Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
  • Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
  • Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
  • Assess change requests of product for impact to design, determine supporting information required for implementation of changes.  

Skills:

  • 2-5 years’ experience preferably in medical device industry
  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive Experienced with ISO 14971, Risk Management Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Education/Experience:

  • Bachelor's degree in mechanical engineering or electrical engineering

Related Jobs

Lab Engineer – Camera Capture

Engineering
 California
$60-70/Hr. on W2
08 Months

Location (mandatory): Sausalito, CA Client brings together a diverse and highly interdisciplinary team of researchers and engineers to create the future of wearable experiences. We are currently seeking systems engineers with a passion for technology to develop the next generation of smart, AI-powered wearable devices.

Python
Bash
Camera
Motion Capture
IMU

Firmware Engineer – Testing & Development

Engineering
 California
$90-92/Hr. on W2
12 Months

Location (mandatory): Redmond, WA or Sunnyvale, CA The main function of a firmware software engineer is to apply the principles of computer science and mathematical analysis to the design, development, testing, and evaluation of the software and systems that make computers work. A typical firmware software engineer designs, develops and tests operating systems-level software, compilers, and network distribution software for medical, industrial, military, communications, aerospace, business, scientific and general computing applications. Years of Experience: 8+ years of industry experience developing and testing low level firmware for embedded systems. 10+ years of solid programming skills using C and C++, and experience developing production code and test applications.

Firmware
C++ Graphics
Display
Test
Automation
CI/CD

Web Developer

Engineering
Remote
06 Months

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.

AI
Python
Backend
Web Development

Systems Modeling, Simulation and Analysis Engineer

Engineering
 Massachusetts
$75-95/Hr. on W2
2 Years

Location (mandatory): Lexington, MA • Develops new and/or integrates existing system simulation frameworks, performance models and algorithms, threat models and command and control models. • Develops software that simulates behavior of users and systems. • Develops, integrates and uses graphical user interfaces and visualization tools. • Models operational environments, performs trade studies via computer simulation and provides decision support for alternative architectures. • Performs operational analysis and mission effectiveness analysis. • May build and design training models.

Matlab
RF
Modeling and Simulation

Technical Engineering Recruiter

Engineering
 Illinois
$45-57/Hr. on W2
06 Months

Location (mandatory): Chicago, IL – Remote 4 - 7+ years. Locate, recruit, interview, hire and/or place professional, managerial and technical candidates and other positions with complex requirements in a technical industry. Qualify candidate's skills and experience and conduct pre submittal interviews to determine a candidate's viability for a position. Requires a 4 year degree and/or relevant experience. Experience in Engineering and technical recruiting. SOFTWARE PROFICIENCY: • ATS (Applicant Tracking Systems) • Google Suites

Workday
ATS
Engineering Recruitment
Technical Recruitment

Full Stack Java Developer

Engineering
 Texas
06 Months

Location (mandatory): Allen, TX This contract position is needed to bolster the US Engineering Team, enabling the fulfillment of feature commitments on our roadmap. You will be an integral part of an Agile team, supporting the full product development lifecycle.

JAVA
JAVASCRIPT
JAVAFX
FlatLaf
CMake
Jenkins

Maintenance Engineer

Engineering
 Connecticut
37
12 months

Location: Groton CT USA 06340 Under minimal supervision, and working within documented operational procedures, maintain facility cGMP mechanical equipment. Lead complex mechanical repairs, perform instrument calibrations, and lock out tag outs supporting facility project upgrades or routine maintenance. Initiate, complete and close on-demand and scheduled work orders. Participate in training other technicians on new equipment and upgrades.

MS Word
MS Excel
verbal communication skills

Network Engineer I

Engineering
 Illinois
06 Months

Location (mandatory): Chicago, IL Our Company has an outstanding track record of success and strives to build long term relationships with our customers. Customer satisfaction is given great emphasis and we strive to build a trusted advisor relationship with every customer. The Chicago team comprises Sales, Project Management, System Engineering and System Technologist personnel working together in a high performance culture, often with demanding cycle times and high customer expectations because we are working on mission critical communication systems. Our core customer uses a large complex network focused around real time video for public safety situational awareness. The system itself is comprised of multiple communication technologies and media types. The role will focus on the design, deployment and documentation of video solutions for this system. The Chicago Systems Engineer will be responsible for overseeing all technical aspects of assigned project(s) from award until system acceptance.

Networking
Wireless Communications
Camera Systems

DevSecOps Systems Engineer

Engineering
 Massachusetts
3 Years

Location (mandatory): Lexington, MA Client is seeking an experienced Systems Administrator to expand and maintain a heterogeneous network of Linux, Windows, OSX, VMware platforms and computer-driven test equipment in support of research into cyber system assessments. A key function of a group Systems Administrator role is to serve as a technology consultant to research staff and project teams. Primary area of expertise for this role will be the Ubuntu operating system.

DevSecops
Ubuntu
Linux
Ansible
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