Sr. Design Assurance Engineer

1 month ago

Eden Prairie, Minnesota, United States Bracco Medical Technologies Full time
Sr. Design Assurance Engineer

LinkedIn
Twitter
Email
Message
Share

Why Join Bracco Medical Technologies?
At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving
decisions. We create medical devices that give healthcare providers the
insights they need to confidently and safely diagnose patients. Our unique line
of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve
(FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast
delivery systems.

Position Description

Position Summary:
The Sr. Design Assurance Engineer position will support design assurance activities for Bracco Medical Technologies (BMT) products.

This role is responsible for providing support for Design Verification and Validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.

This role will act as Subject Matter Expert for Biocompatibility, Micro-biology, Packaging, and Sterilization to support new product development as well as commercialized products.

Manages critical projects for the organization ensuring efficient and effective project reporting and closure. Main focus area includes consumable medical devices for single and multi-use applications.

Primary Duties & Responsibilities:

Design Assurance

  • Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated with consumable products.
  • Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements.
  • Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
  • Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
  • Support risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
  • Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Generate the QA deliverables to meet the project scope and plan.
  • Review, provide input, and approve project-related deliverables and change orders.
  • Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
  • Provide project teams subject matter expertise as it applies to biocompatibility, sterilization, and chemical analysis for Extractable and Leachables, particulates, and multi-use testing.
  • Documents and reports defects found during testing and works with the development team to ensure they are resolved.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.
  • Rigorous documentation for all phases of new product development including specifications, verification test plans, biocompatibility assessments, sterilization protocols, and change orders associated with medical devices and consumable products.
  • Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Maintain project plans, set/adhere to milestones, deliverables and budgets, and manage a limited number of concurrent projects.
  • Ensure that all deliverables are clearly communicated to management including planning, deliverables and timing and defined objectives.
  • Direct outside contract personnel/suppliers/laboratories as needed for completion of specific tasks.

Product Quality Engineering Support

  • Develop and maintain Quality Plans for sustaining and development projects to ensure compliance with established policies, regulations, and customer & design requirements.
  • Act as a SME for Biocompatibility, Chemistry, and Microbiology for new product development and ongoing sustaining projects
  • Work with and manage external laboratory testing including generation of statement of work (SOW) within the project team
  • Provide leadership and QA support for CAPA activities relating to products and process, and leading other efforts relating to quality characteristics and conformance to product requirements.
  • Review and approve change orders related to product/process changes.
  • Participate in internal/external audits as needed.
  • Evaluate corrective actions for effectiveness to assure conformity to quality specifications.
  • Provide leadership and QA support for validation of production and test processes.
  • Provides mentorship to other Quality Engineers on an as needed basis.
Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • B.S. in Engineering (chemical or chemistry) or comparable science discipline; Masters preferred.
  • Minimum 5+ years of Quality Engineering experience in medical device industry, preferably with sterile consumables.
  • Extensive knowledge of process validation, test method validation and R&R study
  • Extensive knowledge of biocompatibility, microbiology, and sterilization methodologies
  • Extensive knowledge of and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA)
  • Extensive knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820
  • Extensive knowledge of risk management and ISO14971
  • Strong written and verbal communication skills to effectively translate ideas, concepts and information
  • Ability to develop clear, concise, and timely oral and written reports
  • Ability to support critical projects that requires advanced problem solving skills and project management oversight
  • Ability to work independently
  • Ability to travel both domestically and internationally

Preferred:


  • Advanced degree-Engineering or Chemistry
  • 7-10 yrs experience, with specific experience in Design Assurance
  • Demonstrated project management skills in order to plan, conduct and implement system assessments
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
  • Knowledge of IEC 60601 and UL Standards
  • Knowledge of USP testing and standards

Other:

  • Travel expected to be less than 15%.
Job Location
7905 Fuller Road, Eden Prairie, Minnesota

Tracking Code


ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with various departments including Marketing, Clinical, Regulatory,...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Overview: A prominent Tier 1 OEM is in search of a Lead Quality Assurance Engineer to enhance their expanding team.About the Role: As a Lead Quality Assurance Engineer, you will play a pivotal role in steering our quality assurance initiatives, ensuring that our production processes adhere to and surpass the highest quality benchmarks.Key...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams,...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Tier 1 OEM seeks Lead Quality Assurance Engineer to enhance our quality initiatives. This Jobot Job is hosted by: Ryan Purdy Salary: $100,000 - $130,000 per year About Us: A premier Tier 1 OEM automotive manufacturer with a rich legacy. Why Work With Us? Competitive compensation Positive work environment Comprehensive benefits Growth opportunities ...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and...

  • Lead Quality Assurance Engineer

    1 week ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Join a Leading Tier 1 OEM as a Lead Quality Assurance Engineer.This Jobot Job is hosted by: Ryan PurdyAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $100,000 - $130,000 per yearAbout Us:We are a prominent Tier 1 OEM automotive manufacturer with a legacy of excellence.Why Work With Us?Attractive...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through innovative therapies.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial in...

  • Mechanical Design Engineer

    1 day ago

    Eden Prairie, Minnesota, United States Actalent Full time

    About the RoleWe are seeking a highly skilled Mechanical Design Engineer to join our Engineering team at Actalent. As a Mechanical Design Engineer, you will be responsible for designing, developing, and documenting hydraulic power units and integrated manifolds, as well as manufacturing-assembly procedures for pumps, motors, and valves.Key...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations....

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of individuals experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams, taking on...

  • Senior Electrical Design Engineer

    1 day ago

    Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full time

    Job SummaryWe are seeking a highly skilled Senior Electrical Design Engineer to join our team at Beacon EmbeddedWorks. As a key member of our engineering team, you will be responsible for leading electrical design projects and ensuring the delivery of high-quality products to our customers.Key ResponsibilitiesLead electrical design projects from concept to...

  • Lead Software Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States ACIST Medical Systems Full time

    Why Join ACIST Medical Systems?At ACIST Medical Systems, we are dedicated to making a difference in healthcare through innovative medical technologies. Our advanced medical devices provide healthcare professionals with the essential tools to make informed and timely decisions for patient care.Position Overview:The Lead Software Quality Assurance Engineer is...

  • Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full time

    Position OverviewROLE SUMMARYThe Quality Assurance Engineer is responsible for delivering technical support and manufacturing assistance across all facets of product and process quality. This includes conducting root cause investigations, gathering data, and formulating plans for incoming quality assurance.Reporting Structure: Reports to the Senior Manager...

  • Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full time

    CORPORATE OVERVIEW The Organization Beacon EmbeddedWorks is a comprehensive provider of embedded solutions. Its cutting-edge System on Modules (SOMs) are supported by a broad range of customization, security, and support services, with a dedicated team of specialists offering in-house manufacturing and assistance to expedite development and mitigate risks....

  • Electrical Design Engineer

    3 months ago

    Eden Prairie, Minnesota, United States National Diversity Network Full time

    Eden Prairie, MN, USAFull time R24_ SUMMARY:The Electrical Design Engineer provides CAD designs, technical specifications, product selection/configuration, and production support for Value Added business in alignment with customer specifications and strategic plan.JOB DUTIES:Collaborates with sales staff for final quote preparation and delivery to...

  • Quality Assurance Specialist

    2 weeks ago

    Eden Prairie, Minnesota, United States Stratasys Full time

    Quality Assurance SpecialistLocation: Eden Prairie, MN, USJob ID: 53740Category: Manufacturing & OperationsAbout Stratasys:Stratasys stands at the forefront of 3D printing technology, driving the global transition to additive manufacturing. Our innovative solutions cater to diverse sectors including aerospace, automotive, consumer goods, and healthcare. By...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various components of the Quality Management System, focusing on product and process quality,...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various facets of the Quality Management System, focusing on product/process quality, supplier...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various facets of the Quality Management System, focusing on product and process quality, supplier...

  • Bridge Design Engineer

    4 days ago

    Eden Prairie, Minnesota, United States Selectek Full time

    Job SummaryWe are seeking a highly skilled Bridge Design Engineer to join our team at Selectek. As a key member of our engineering team, you will be responsible for designing bridges, including cast-in-place and precast bridges, from concept to fabrication drawings.Key ResponsibilitiesDesign bridges using reinforced concrete, prestressed concrete, steel, and...