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Principal Design Assurance Engineer

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Location
MN
Job Type
Direct Hire
Date
Nov 27, 2018
Job ID
2642435

Our 15-person, start-up medical device client is developing a novel, minimally invasive technology for structural heart disease.  The team is adding a Principal Design Assurance Engineer who will report to the Sr. Director of Quality. The Design Assurance Engineer will be responsible for new product development (conception to launch) and sustaining projects. Lead for the planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.Continued support and optimization of New Product Development deliverables and processes, accounting for cross functional system interactions.


Your role with the company:

  • Manage a team of design assurance engineers and technicians – including mentoring, training, assigning tasks, and providing work direction.

  • Participate and lead New Product Development Phase Reviews and Design Reviews.

  • Partner with R&D to determine and define design inputs, design outputs, and design

    input/output relationships.

  • Create and support the development and validation of new test methods.

  • Determine and document risks associated with the product (Hazard Analysis, dFMEA,

    pFMEA, uFMEA).

  • Develop the strategy and manage the execution of design verification and validation.

  • Generate test protocols, manage test execution, investigate test issues, analyze data,

    and create reports for design verification and validation testing.

  • Develop, execute, and manage First Article inspections.

  • Support regulatory approvals and responses to regulatory questions.

  • Provide direction to design assurance engineering and technicians supporting assigned

    projects.

  • Review and improve design assurance specific quality system deliverables and

    processes to increase effectivity and efficiency.

  • Support the transfer of new product development projects from development to

    production.

  • Experience with transcatheter valve technologies would be an added advantage.

  • Ability to manage a team of technicians.

  • Ability to lead cross functional teams.

  • Proficient in technical report writing and review.

  • Structured and methodical problem-solving approach

  • Thorough understanding of design controls, risk management, statistics, test method

    validation, and new product development processes.

  • Thorough understanding of industry regulations such as ISO13485 and FDA QSR’s.

  • Assist in establishing work direction and supervision of Design Assurance staff.


    Desired Profile:

  • Minimum of a bachelor’s degree in a technical field or equivalent experience.

  • Must have 5-10 years of related professional experience.

  • Intimate knowledge of ISO 13485, Canadian Medical Device Requirements, CE Marking, EU MDR

    (former MDD), FDA Medical Device Regulation (MDR) and FDA requirements.

  • Considerable knowledge of manufacturing processes and practices as applicable to the company's

    products.

  • Experience in quality management, production management, industrial technology or related

    areas. Considerable experience in working with top management and senior levels of customer's

    organizations.

  • Ability to multi-task in a fast-paced work environment necessary to be successful.

  • Ability to work in a team environment across all levels of the organization is essential.

  • Ability to manage subordinates, projects and workflow effectively is a must.

  • Possess exceptional organizational skills with the ability to manage multiple priorities.

  • Detail oriented and demonstrated ability to remain flexible to meet the Company’s evolving

    requirements.

  • Knowledge of statistics, data collection, analysis, and data presentation.

  • Ability to work in a fast-paced, constantly changing environment.

  • Ability to problem-solve, work under pressure, and to effectively manage stress.

  • Ability to work overtime as needed.