VVentis Medical is in full-scale production of HeroVent, the next-generation portable ventilator cleared under FDA 510(k). We need an engineer who can bridge Electrical, Mechanical, Software, and Manufacturing Engineering to support manufacturing and our contract manufacturer to drive quality and capacity.

The ideal candidate possesses both a high level of technical expertise and an innate passion to build. You will play a critical role in creating and refining designs and processes in order to improve the product design, manufacturability, quality, and productivity.

You will manage and oversee the manufacturing of a medical device by our contract manufacturer. Real world experience in medical device development, production, and quality processes under FDA good manufacturing practices and ISO standards required.

DUTIES AND RESPONSIBILITIES:

Oversee the manufacturing of an FDA regulated medical device
Contribute to the design of specific components
Create and maintain structured, multi-level BOMs ensuring linkage between CAD and ECOs
Generate and drive Engineering Change Requests/Orders (ECR/ECO); document rationale, verification and validation
Act as the a technical liaison to injection molders, machining houses, PCB fabs, and EMS partners - translating GD&T, cosmetic standards, and regulatory requirements into clear supplier deliverables
Create and maintain work instructions and manufacturing specifications
Collaborate cross-functionally to facilitate production process and evaluate potential changes
Executing design change implementations and supports the overall design change process
Evaluating the manufacturing processes for opportunities in productivity gains
Identifying manufacturing issues (design/process/component) and drive resolution by participating on cross-functional or project teams
Prepare all documentation in accordance with FDA regulations including 21 CFR Part 11
Perform verification/validation to confirm design specifications and evaluate potential failure modes
Coordinate project schedule with customers, supply chain, internal resources, and supervisors
Documentation and organization of design-related data / technical drawing packages following design and revision controls per ISO 9001 and internal standard practice. Knowledge of ISO 13485 is desired
Work independently on assignments and multi-task on several projects

QUALIFICATIONS:

At least 3 years direct relevant experience in medical device manufacturing
Bachelor's Degree or higher in Mechanical Engineering or Industrial Engineering
On site in Carrollton, Tx (Required majority of time)
Excellent oral and written communication skills
FDA/ISO/Med Device experience required
Willing to travel up to 10%

Ventis Medical

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