Senior Quality Engineer

4 weeks ago

Lisle, United States Ontogen Medtech Full time

Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care.


Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will possess extensive knowledge and expertise in quality management within the medical device industry, with a focus on design, manufacturing, and supplier quality. Reporting to the Co-Founder, this individual will play a crucial role in ensuring compliance with regulatory standards and quality systems, driving product quality, and initiating continuous improvement, both for Ontogen and for our clients.


Responsibilities

  • Lead quality assurance activities throughout the product lifecycle, from design quality to manufacturing and post-market.
  • Assess and mitigate quality risks associated with product design, review DHF documentation, evaluate component risk, and identify critical features.
  • Develop and implement quality plans and inspection procedures, and test methods.
  • Evaluate and qualify client suppliers, evaluate manufacturing processes and supplier operations.
  • Conduct and lead quality audits to ISO 13485 standards, ensuring compliance and identifying areas for improvement.
  • Collaborate closely with cross-functional teams including internal and client team members throughout the development process.
  • Investigate non-conformances, root causes, and corrective/preventive actions to drive process improvements and prevent recurrence.
  • Provide guidance and support to internal stakeholders on quality-related issues, ensuring adherence to regulatory requirements and industry best practices.
  • Provide support for on-market products, including advising contract manufacturers and making independent decisions regarding the disposition of non-conforming products.
  • Serve as a subject matter expert on quality standards, regulations, and industry trends, keeping abreast of changes and proactively implementing updates as necessary.


Qualifications

  • Bachelor's degree in engineering or related field.
  • Minimum of 8 years of experience in quality engineering role(s) within the medical device industry.
  • In-depth knowledge of quality management systems, regulatory requirements, and standards, including ISO 13485.
  • Proven experience in conducting ISO 13485 quality audits and implementing corrective/preventive actions.
  • Strong understanding of design control processes, manufacturing processes, and supplier management.
  • Proficiency in risk management methodologies.
  • Excellent analytical and problem-solving skills, with a keen attention to detail.
  • Effective communication and interpersonal skills, with the ability to collaborate across teams and with clients and suppliers.
  • Demonstrated ability to work independently and make sound decisions in a fast-paced environment.
  • Experience working in a startup or small company environment strongly preferred.


Ontogen offers a comprehensive and competitive benefits package for employees, including quarterly performance bonuses, 401(k) matching, medical/dental/vision insurance, and unlimited PTO. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire.


Applicants must be currently authorized to work in the United States on a full-time basis. Please note that we are unable to sponsor visas for this position at this time.

*Ontogen Medtech is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.*

  • Senior Quality Engineer

    2 months ago

    Lisle, United States Ontogen Medtech Full time

    Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care. Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will possess...

  • Senior Quality Engineer

    1 week ago

    Lisle, United States Ontogen Medtech Full time

    Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care. Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will...

  • Senior Quality Engineer

    4 weeks ago

    Lisle, United States Ontogen Medtech Full time

    Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care. Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will...

  • Senior Quality Engineer

    2 months ago

    Lisle, United States Ontogen Medtech Full time

    Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care.Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will possess...

  • Senior Quality Engineer

    4 weeks ago

    Lisle, United States Ontogen Medtech Full time

    Ontogen Medtech is a leading provider of design and development services for medical devices. Committed to innovation and excellence, we specialize in delivering cutting-edge solutions that improve outcomes and advance patient care.Ontogen Medtech is seeking a dynamic and experienced Senior Quality Engineer to join our team. The ideal candidate will possess...

  • Senior Quality-Reliability Engineer

    2 days ago

    Lisle, United States Navistar Full time

    Position Overview: We are seeking a Senior Quality-Reliability Engineer to support our transformation as we transition to the TRATON One PDP methodology. This role will lead quality improvement efforts on Body, Exteriors, and HVAC systems across Navistars products. You will leverage your technical system expertise and combine it with problem solving...

  • Senior Supplier Quality Analyst

    2 weeks ago

    Lisle, Illinois, United States Navistar Full time

    Position Overview Navistar is currently seeking a Senior Supplier Quality Analyst. This position will manage suppliers in the chassis and metal components group consisting of stamped, fabricated and roll form components as well as suspension and wheel suppliers. Focus will be ensuring proactive involvement in supplier selection for evaluation of Quality...

  • Senior Supplier Quality Analyst

    2 weeks ago

    Lisle, United States Navistar Full time

    Position Overview Navistar is currently seeking a Senior Supplier Quality Analyst. This position will manage suppliers in the chassis and metal components group consisting of stamped, fabricated and roll form components as well as suspension and wheel suppliers. Focus will be ensuring proactive involvement in supplier selection for evaluation of Quality...

  • Senior Project Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods....

  • Senior Project Engineer

    1 month ago

    Lisle, United States Navistar Full time

    Position Overview We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods....

  • Senior Project Engineer

    2 weeks ago

    Lisle, Illinois, United States Navistar Full time

    We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods. Design solutions must...

  • Senior Project Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods....

  • Senior Project Engineer

    1 month ago

    Lisle, United States Navistar Full time

    Position Overview: We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods....

  • Senior Project Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview: We are seeking a Senior Project Engineer within Body Exteriors team, who will lead in the development of Vehicle Exterior concepts, Requirements Definition, Design Validation Planning, Design & Release, BOM management, Engineering Change Management, and Issue Resolution, and will be expected to work independently for extended periods....

  • Senior Reliability Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview: We are seeking a Senior Reliability Engineer to support our transformation as we transition to the TRATON One PDP methodology. This role will lead quality improvement efforts on Body, Exteriors, and HVAC systems across Navistars products. You will leverage your technical system expertise and combine it with problem solving techniques in...

  • Senior Reliability Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview: We are seeking a Senior Reliability Engineer to support our transformation as we transition to the TRATON One PDP methodology. This role will lead quality improvement efforts on Body, Exteriors, and HVAC systems across Navistars products. You will leverage your technical system expertise and combine it with problem solving techniques in...

  • Multibody Dynamics Simulation Senior Engineer

    6 days ago

    Lisle, United States Navistar Full time

    Position Overview Navistar International Corporation is a leading North American truck manufacturer with great products, a strong market position and best-in-class distribution networks. We have an exciting new opportunity for a Multibody Dynamics Simulation Engineer to join our Research and Development team at our WHQ in Lisle, IL. The Multibody Dynamics...

  • Multibody Dynamics Simulation Senior Engineer

    1 month ago

    Lisle, United States Navistar Full time

    Position Overview: Navistar International Corporation is a leading North American truck manufacturer with great products, a strong market position and best-in-class distribution networks. We have an exciting new opportunity for a Multibody Dynamics Simulation Engineer to join our Research and Development team at our WHQ in Lisle, IL. The Multibody Dynamics...

  • Multibody Dynamics Simulation Senior Engineer

    4 weeks ago

    Lisle, United States Navistar Full time

    Position Overview: Navistar International Corporation is a leading North American truck manufacturer with great products, a strong market position and best-in-class distribution networks. We have an exciting new opportunity for a Multibody Dynamics Simulation Engineer to join our Research and Development team at our WHQ in Lisle, IL. The Multibody Dynamics...

  • Senior Project Engineer

    1 month ago

    Lisle, United States Navistar Full time

    Position Overview Navistar is currently seeking a Senior Project Engineer to join our team! In this role, you will work in the Base software Verification & Validation team as a Sr. Project Engineer. You will play a significant role in verification and troubleshooting of unit/functional automated testing solutions. You will be accountable for the overall...