Sr. Pilot Engineering Manager
Company: Balt USA
Posted on: November 18, 2021
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
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
- 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
- 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
- Experience with Risk Analysis and Risk Management requirements
- 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
- 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.
- 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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