Balt is looking to improve the manufacturing processes for neurovascular medical devices to enhance safety, quality, output, and cost, and to ensure the flawless integration of new products into the manufacturing environment.
Requirements
- Class II, IIb, or III Medical Device Experience
- Deep process validation knowledge in medical device or pharmaceutical experience is required.
- Equipment Development and Qualification experience
- Working knowledge of statistical analysis of various data types for the purpose of validation and process control/monitoring
- Neurovascular experience is a plus
- Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
- Experience creating, reading, interpreting and updating technical drawings for tooling/fixturing/equipment as well as part/product applications
Responsibilities
- Lead a team of Manufacturing Engineers and Technicians in supporting the ongoing manufacturing of commercial products as well as ensuring flawless integration of new products into the manufacturing environment.
- Daily work includes leadership and execution in both sustaining and project work –complete the types of projects that remove the need for engineering intervention– improving safety, quality, output and cost.
- Provide support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met.
- Further, improve systems to monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
- Interface with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.
- Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA's QSR and cGMP and a good understanding in statistics.
- Creation and maintenance of models for product cost and capacity to help prioritize engineering and production resources related to improvement projects.
Other
- Four-year technical degree required(Bachelor's), preferably in Engineering.
- 5 years minimum as an Engineer or engineering leader in a related field with at least 1 year being in a leadership/management role.
- Ability to train and manage engineers and technicians in various procedures and skillsets needed to maintain and improve commercial manufacturing
- Directing engineers who lead project teams tasked with manufacturing improvement projects, manufacturing transfers as well as successful transfers into manufacturing.
- Comfortable working independently and cross-functionally as part of a team
