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Sr. Pilot Engineering Manager

Company: Balt USA
Location: Irvine
Posted on: November 18, 2021

Job Description:

Are you interested in being part of a unique corporate story, one which involves partnering with physicians to create life-saving innovation? As the Sr. Pilot Engineering Manager you will have a direct impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company. In this role, you will be responsible for leading a team of engineers in multiple areas related to validation and verification of products from new product development, market access requirements, remediation activities and technology transfers/acquisitions.
You are responsible for (but not limited to):

  • Daily work focuses on managing a team of engineers and technicians in activities related to design transfer, testing to support regulatory registrations and remediation testing as required. Developing, updating and reviewing procedures to make sure they are adequate to ensure compliant and efficient completion of activities. Meeting with cross-functional teams to help provide guidance and technical oversight to the project teams as well as reporting project status to necessary stakeholders.
  • Provide support to the Manufacturing organization to facilitate efficient transfer of technologies or newly developed products into the production area ensure that production goals are met. This includes being the interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
  • Both Design Verification/Validation testing support and Process validation and verification execution is a main responsibility of the Pilot Engineering team so this position must have knowledge of internal and external requirements for these elements in order to provide guidance to the project teams.
  • This position is also responsible to help in project planning, resourcing and budgeting to help support business requirements.
    To succeed in this role, you should have the following skills and qualifications:
  • Four-year degree required in Engineering.
  • Class II or III Medical Device Experience
  • Minimum experience required is 5 years in a related field with at least 2 of those being in a management position.
  • Experience with new product development in medical devices
  • Experience with design/technology transfer in the medical device industry.
  • Neurovascular specific experience is a plus
  • Directing engineers who lead project teams tasked with technology transfer, product remediation, product development and the successful transfers into manufacturing
  • Understanding of V&V testing for new product designs
  • Ability to prepare project plans, specifications, and schedules for cross-functional projects
  • Experience with catheters, balloons, or stents design testing and manufacturing processes and equipment.
  • Familiar with 510K Testing for FDA approval
  • Knowledge to develop and improve R&D processes to pilot production level
  • Experience with Risk Analysis and Risk Management requirements and documentation.
  • Application of statistical and analytical methods such as SPC, SQC, and DOE
  • Process background (development, capability, optimization, validation) within the medical device industry
  • Development of manufacturing documentation to support effective design transfer (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders)
  • Proficiency in SolidWorks
  • Comfortable working independently and cross-functionally as part of a team
  • Developing and managing metrics to gauge and manage team performance.
  • Up to 20% European International travel required
    BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide. We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.
    Diverse workforces create the best culture, company, and products! We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.
    Physical Requirements
  • Extended periods of sitting.
  • Extended usage of a microscope.
  • Moderate lifting.

Keywords: Balt USA, Irvine , Sr. Pilot Engineering Manager, Executive , Irvine, California

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