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
- Release controlled CAD/STEP/DXF packages, review tool-design and steel-safe changes, and approve first-article samples (FAI)
- Rapid-prototype concepts with 3-D printing, CNC, and casting techniques
- 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
- Researching and resolving electro-mechanical, production assembly and/or test issues in a timely manner
- Prepare all documentation in accordance with FDA regulations including 21 CFR Part 11
- Creating new templates updating and revising Supplier Quality Agreements and quality requirement
- Perform detail risk assessment based on patient safety, product quality and data integrity
- 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%
