Title: Medical Device Quality Engineer

4 weeks ago


Lafayette, United States MasterCompliance LLC Full time

Job DescriptionJob Description

Title: Medical Device Quality Engineer

Location: Lafayette, CO (Onsite)

Type: W2 contract.

We have Mid-level and senior level openings for below positions.

6+ Years design experience in medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management.

Top 3 technical skills that you are required for the role:

1. CAPA

2. Medical device risk management

3. Compliance effective oversight

Education Required: Bachelor’s Degree in Engineering, Science or technical field with 6+ years of work experience in Engineering and/or Quality.

Job description:

Responsibilities may include the following and other duties may be assigned.

A representative for the Released Product Management (RPM) Design Quality team on projects that address day-to-day quality issues of the market-released products.

Compliance effective oversight with the RPM activities per the applicable Standard Operating Procedures (SOP's) and External Standards as part of the process.

Contribute and lead activities during the following activities:

Risk analysis, including product risk assessment ownership, key stakeholder to various Failure Mode and Effects Analysis, and assessing specific product issues for impact to patient and/or user safety and product quality

Drawing and specification reviews

Verification and Validation testing and reporting

Product performance reviews

Test method validation

DHF audits

Mechanical drawing review and approval per ASTM-14.5Y.

Technical problem-solving compiles data and prepares reports on findings to identify trends proposes corrective action as needed.

Collaborates with RPM project cross-functional team to ensure quality standards are in place.

Specialize in RPM risk management, test method validation, and equipment

calibration/qualification/validation.

#J-18808-Ljbffr



  • Lafayette, United States MasterCompliance LLC Full time

    Job DescriptionJob Description Title: Medical Device Quality Engineer Location: Lafayette, CO (Onsite) Type: W2 contract. We have Mid-level and senior level openings for below positions. 6+ Years design experience in medical device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience...


  • Lafayette, United States Redbock - an NES Fircroft company Full time

    Software Quality Engineer II (6 month contract, opportunity for extension // Lafayette, CO):Alternative title: Software Design Quality Engineer IITop Skills:Strong experience with Software Quality and SDLC activitiesExperience with software design changes from CAPA/Post Market feedbackExperience with Risk Management activities/documentation, including...


  • Lafayette, United States Redbock - an NES Fircroft company Full time

    Software Quality Engineer II (6 month contract, opportunity for extension // Lafayette, CO):Alternative title: Software Design Quality Engineer IITop Skills:Strong experience with Software Quality and SDLC activitiesExperience with software design changes from CAPA/Post Market feedbackExperience with Risk Management activities/documentation, including...


  • Lafayette, United States Redbock - an NES Fircroft company Full time

    Software Quality Engineer II (6 month contract, opportunity for extension // Lafayette, CO):Alternative title: Software Design Quality Engineer IITop Skills:Strong experience with Software Quality and SDLC activitiesExperience with software design changes from CAPA/Post Market feedbackExperience with Risk Management activities/documentation, including...


  • Lafayette, United States GROVE TECHNICAL RESOURCES, INC Full time

    Responsibilities:Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Define appropriate measures to ensure software quality. Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development...


  • Lafayette, United States Grove Technical Resources, INC Full time

    Responsibilities:Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Define appropriate measures to ensure software quality. Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development...


  • Lafayette, United States Grove Technical Resources, INC Full time

    Responsibilities:Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Define appropriate measures to ensure software quality. Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development...


  • Lafayette, United States GROVE TECHNICAL RESOURCES, INC Full time

    Responsibilities: Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Define appropriate measures to ensure software quality. Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development...


  • Lafayette, United States Primary Talent Partners Full time

    Primary Talent Partners has a 6 month contract opening for a Software Quality Engineer II to join a multinational medical device company for an onsite position in Lafayette, CO. Assignment Type: You will be sitting on a W2 with Primary Talent Partners - We cannot provide sponsorship or accept C2C candidates for this assignment. Pay: $55.00/hr - $60.00/hr...


  • Lafayette, United States Primary Talent Partners Full time

    Primary Talent Partners has a 6 month contract opening for a Software Quality Engineer II to join a multinational medical device company for an onsite position in Lafayette, CO. Assignment Type: You will be sitting on a W2 with Primary Talent Partners - We cannot provide sponsorship or accept C2C candidates for this assignment. Pay: $55.00/hr - $60.00/hr...


  • Lafayette, United States Primary Talent Partners Full time

    Primary Talent Partners has a 6 month contract opening for a Sr Software Quality Engineer with a Medical Device Client of ours in Lafayette CO. This role is onsite. Pay Range: $55 to $65 per hour Top 3 technical skills that are required for the role: Risk management: experience in assessing and mitigating risks associated with SW development in medical...


  • Lafayette, United States Primary Talent Partners Full time

    Primary Talent Partners has a 6 month contract opening for a Sr Software Quality Engineer with a Medical Device Client of ours in Lafayette CO. This role is onsite. Pay Range: $55 to $65 per hour Top 3 technical skills that are required for the role: Risk management: experience in assessing and mitigating risks associated with SW development in medical...


  • Lafayette, United States LanceSoft Full time

    JOB DESCRIPTION This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities: New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team; Post Market Release...


  • Lafayette, United States LanceSoft Full time

    JOB DESCRIPTION This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities: New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team; Post Market Release...


  • Lafayette, United States Artech Full time

    Job Title: Sr Manufacturing Engineer Job ID:13388 Location:200 Client Dr Bldg 2 Lafayette Colorado 80026 Duration: 12 Months Contract Pay rate - $50- $55/hr on W2 Top 3 technical skills that you are required for the role: Process Validation Design of Experiments Gauge R&R This position is for an Advanced Manufacturing Engineer. This role...


  • Lafayette, United States Compliance Group Inc Full time

    Job Title - Sr Mechanical Design EngineerJob Location - Lafayette, Colorado (Fully Onsite)Type: W2 contract Job Description:In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality....


  • Lafayette, United States Compliance Group Inc Full time

    Job Title - Sr Mechanical Design EngineerJob Location - Lafayette, Colorado (Fully Onsite)Type: W2 contract Job Description:In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality....


  • Lafayette, United States Grove Technical Resources, INC Full time

    Responsibility: Ensures that suppliers deliver quality parts, materials, and services.Qualifies suppliers according to company standardsMonitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.Generates 3D models and prints with a strong undertanding of GD&T fundementalsEvaluates...


  • Lafayette, United States GROVE TECHNICAL RESOURCES, INC Full time

    Responsibility: Ensures that suppliers deliver quality parts, materials, and services.Qualifies suppliers according to company standardsMonitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.Generates 3D models and prints with a strong undertanding of GD&T fundementalsEvaluates...


  • Lafayette, United States GROVE TECHNICAL RESOURCES, INC Full time

    Responsibility: Ensures that suppliers deliver quality parts, materials, and services.Qualifies suppliers according to company standardsMonitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.Generates 3D models and prints with a strong undertanding of GD&T fundementalsEvaluates...