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Sr Manufacturing Engineer
2 months ago
About Visby
Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world's first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
About the Job
Sr Manufacturing Engineer - Mechanical Design and Automation will be responsible for the component and subassembly design improvements for manufacturing, development and support of manufacturing processes and equipment to enable safe, high-quality, cost-effective manufacturing of our products.
How You'll Make an Impact
- Maintain a safe and open working environment.
- Design and develop assembly tooling and process design
- Design and develop robotic plastic welding (laser or ultrasonic) / material handling cells
- Design and develop mechanical assembly cells
- Develop and implement capital or expense projects to include researching new and established manufacturing technologies, planning the capital and time needed to implement the technology, writing CER (Capital Expenditure Request) proposals to be reviewed.
- Procure Equipment
- Generate and manage device and equipment CAD models, drawings and assemblies under BOM structure in SW PDM
- Draft and maintain equipment manuals and work instructions
- Execute and support equipment and process installation and qualification activities
- Operate under the guidelines of GMP/Company QMS.
- Contribute to continuous improvement to manufacturing efficiency, product quality, and the team's morale.
- Manage the manufacturing engineering design process (concept, design, drawing creation, build, documentation), installation, and long-term technical support of the manufacturing processes and equipment while meeting quality, capability, cost and time targets.
- Follow established quality policies and adhere to operating procedures and guidelines.
On Your First Day We'd Like You to Have
- BS in engineering and 8 years relevant experience
- MS degree in engineering discipline is a plus.
- Experience in automation cell design and layout preferred
- 3D modeling experience is required. SolidWorks and PDM Vault
- Candidate must demonstrate an ability to read and understand mechanical drawings and GD&T
- ISO environment (FDA regulated Medical Device industry is a plus)
It's Great If You Have
- Ability to work independently as well as in a team through technical issues.
- Strong analytical and technical problem-solving ability
- Excellent communication skills with attention to detail.
Unique Aspects of the Job
- Ability to lift a minimum of 20 lbs.
- Ability to move about the manufacturing facility (access files/storage, office equipment, computers and other productivity devices; plan, organize, and attend manufacturing meetings; attend to various issues on the shop floor; etc.), is required.
- Must be able to lead the physical assembly of his/her own mechanical/electrical machine designs, making adjustments as needed
- Work within a low humidity environment (