Design Assurance Engineer

4 weeks ago


Saint Paul, United States Ativa Medical Corporation Full time
Job DescriptionJob Description

Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.

Essential Job Duties & Skills:

· Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.

· Manage tracability of design requirements through risk mitigation and design verification

· Technical writing and critical review of design verification plans, procedures, test protocols and reports.

· Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records

· Lead key equipment qualification efforts

· Lead supplier management activities

· Review and evaluate non-conforming materials.

· Work with vendors to correct material non-conformances

· Generate inspection procedures for both incoming parts and on-site production.

· Review manufacturing documentation for accuracy and clarity.

· Contribute to process validation activities

· Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management

· Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.

Additional Job Expectations:

· Being aligned with team goals and supportive in a team environment

· Sound communication in collaborations with other company functions (written and verbal)

· Using good judgment when confronted with choices

· Being organized, thorough in prioritizing and generating work products

· Being both proactive and professional

Education and Experience:

· BS in Mechanical Engineering or a related field

· 5+ years of Design Assurance in Life Sciences Industry
IVD medical device environment a plus

· Experience with statistical methods and terminology

· Demonstrated structured problem-solving skills



  • St Paul, United States Ativa Medical Full time

    Job Description Job Description Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities. Essential Job...


  • Saint Paul, United States Minnesota Department of Transportation Full time

    Would you like to be part of a team that leads the way in the newest directions of highway and street design? MnDOT’s Design Flexibility Unit implements the industry’s newest practices of flexible and performance-based design throughout the agency and statewide engineering community. We operate at the cutting edge of innovation and exploration.In this...


  • Saint Paul, United States TKDA Full time

    Our employee-owned and integrated team of multi-discipline engineering and design professionals is looking for a CAD Designer / Engineering Specialist who has extensive experience developing civil designs for varied site design projects within the manufacturing / industrial, private development, renewable energy, education, and municipal / government...


  • Saint Paul, Minnesota, United States TKDA Full time

    Our employee-owned and integrated team of multi-discipline engineering and design professionals is looking for a CAD Designer / Engineering Specialist who has extensive experience developing civil designs for varied site design projects within the manufacturing / industrial, private development, renewable energy, education, and municipal / government...


  • Saint Paul, Minnesota, United States TKDA Full time

    Our employee-owned and integrated team of multi-discipline engineering and design professionals is looking for a CAD Designer / Engineering Specialist who has extensive experience developing civil designs for varied site design projects within the manufacturing / industrial, private development, renewable energy, education, and municipal / government...


  • Saint Paul, United States KLM Careers Full time

    Job DescriptionJob DescriptionSr. Controls Design EngineerSaint Paul, MN Must be a US Citizen or Green Card holder.Industry Leading provider of water, wastewater, and industrial controls with a proven history of innovation and excellence. Our experienced sales staff, programmers, technicians, and project engineers are here to serve you.This position is...


  • Saint Paul, United States Automationtechies Full time

    Job DescriptionJob DescriptionJoin a Systems Integrator providing water, wastewater, and industrial controls for over 50 years. The opportunity for you to advance your career is unlimited with this company. They are an industry leader and have even been awarded the prestigious Allen-Bradley System Integrator Circle of Excellence Award!This Senior Design...


  • Saint Paul, United States ForwardEdge ASIC (a Lockheed Martin Company) Full time

    Job DescriptionJob DescriptionForwardEdge ASIC is seeking skilled and detail-oriented ASIC Analog SERDE designers to join our talent network. The successful candidates will be responsible for the circuit design of high-speed SERDES analog/mixed-signal circuits within ASIC designs. This role involves collaborating closely with customers and cross-functional...


  • Saint Paul, United States Automatic Systems Co Full time

    Job DescriptionJob DescriptionAutomatic Systems Company is an industry-leading provider of water, wastewater, and industrial control systems. We are dedicated to delivering innovative solutions and exceptional service to our clients. With a focus on excellence and continuous improvement, we strive to make a significant impact in the field of automation and...


  • Saint Paul, United States Automationtechies Full time

    Job DescriptionJob DescriptionJoin a Systems Integrator that has been providing water, wastewater, and industrial controls for 50 years. The opportunity for you to advance your career is unlimited with this company. They are an industry leader and have even been awarded the prestigious Allen-Bradley System Integrator Circle of Excellence Award!Job Summary:As...


  • Saint Paul, United States TKDA Full time

    Our employee-owned and integrated team of multi-discipline engineering and design professionals has an opportunity available for a Professional Highway Design Engineer to join our team in Saint Paul! As a member of our team, you will work alongside a group of engineers, designers, and technicians who have established a reputation for designing complex,...


  • Saint Paul, United States TKDA Full time

    Our employee-owned and multi-disciplined team of engineering and design professionals is looking for a Graduate Engineer to join our team. If you are a recent or upcoming graduate interested in highway design, consider joining our team here in St. Paul! As a member of our Surface Transportation team in downtown Saint Paul, you will apply your academic and...


  • Saint Paul, United States Automatic Systems Co Full time

    Job DescriptionJob DescriptionSince 1967 Automatic Systems Company is an Industry Leading provider of water, wastewater, and industrial controls with a proven history of innovation and excellence. Our experienced sales staff, programmers, technicians, and project engineers are here to serve you.This position is responsible for engineering electrical controls...

  • Controls Engineer

    4 weeks ago


    Saint Paul, United States Summit Machine Inc Full time

    Job DescriptionJob DescriptionSummit Engineered Automation is looking for a highly motivated individual to support our Automation Team in designing and building automation and robotic equipment that produces a wide range of products. The ideal candidate will possess the necessary skills to bring a machine from concept to installation; this includes...

  • Controls Engineer

    4 weeks ago


    Saint Paul, United States Summit Machine Inc Full time

    Job DescriptionJob DescriptionSummit Engineered Automation is looking for a highly motivated individual to support our Automation Team in designing and building automation and robotic equipment that produces a wide range of products. The ideal candidate will possess the necessary skills to bring a machine from concept to installation; this includes...


  • Saint Paul, United States Serigor Inc Full time

    Job Title: Quality Assurance Analyst (Hybrid)Location: St. Paul, MNDuration: 2 YearsJob Description:The client is seeking a Quality Assurance Analyst to work in the client At a high level, the resource will work on multiple initiatives including the Predatory Offender Registry (POR), My BCA (a secure criminal justice portal), and other products as needed....


  • Saint Paul, United States Serigor Inc. Full time

    Job DescriptionJob DescriptionJob Title: Quality Assurance Analyst (Hybrid)Location: St. Paul, MNDuration: 2 YearsJob Description:The client is seeking a Quality Assurance Analyst to work in the client At a high level, the resource will work on multiple initiatives including the Predatory Offender Registry (POR), My BCA (a secure criminal justice portal),...


  • Saint Paul, United States TKDA Full time

    Are you looking for an opportunity that will take your career to new heights? Are you an experienced Professional Civil Engineer who has a strong interest in transportation engineering, and more specifically within the aviation sector? Are you looking for an opportunity where you can make an impact, work on a variety of projects, and be provided with...

  • Mechanical Engineer

    2 days ago


    Saint Paul, Minnesota, United States NV5 Full time

    Mechanical EngineerJob ID# of Openings: 1Job Locations: US-MN-Saint PaulCategory: EngineeringType: Regular Full-TimeOverviewAre you a natural problem solver? We are seeking passionate and driven Mechanical Engineers to be part of our Mechanical Building Systems Team, dedicated to providing innovative engineering solutions in areas such as Higher Education,...


  • Saint Paul, Minnesota, United States KLM Careers Full time

    Sr. Controls Design Engineer Saint Paul, MN Must be a US Citizen or Green Card holder. Industry Leading provider of water, wastewater, and industrial controls with a proven history of innovation and excellence. Our experienced sales staff, programmers, technicians, and project ...