Development and execution on a strategy for processing capabilities to meet the current and future needs of the organization.
Facilitate the development of subject matter expertise for process development, process characterization, and validation.
Lead the development of a customer centric department that is highly responsive to customer needs.
Preparing all quotations for Gloucester and sending to our sales team and or customers as directed.
Educate members of the team about the relationship between their work and achieving project and company objectives.
Act as the lead technical resource for manufacturing processes, equipment, and capabilities.
Effectively communicate across teams (Operations and Productions) the project goals and objectives to align expectations both within the company and with our clients.
Collaborate with other Managers and with other departments to maintain alignment of corporate objectives.
Assist the development and change management of manufacturing transfer cost of goods sold (TCOGS) for new and sustaining products.
Partnering with Operations, ensure proper support and prioritization is provided to production on injection molding, assembly and packaging processes; troubleshoots process issues as required.
Maintain working knowledge of new techniques, technologies and concepts in order to improve operations and resolve problems.
Takes initiatives in improving productivity and reducing scrap/reject rates and Engineering Waste through automation, tool design, process optimization for driving cost by achieving KPI Targets
Provides leadership and support to the APQP process, coordinating with Operations, Sales, Quality, and Program Managers to achieve the flawless launch of new products and processes.
Interfaces with customers and suppliers on process/tool matters, mold and fixture design, process capability studies, product quality issues,
Support mold validations (IQ, OQ, PQ) to ensure mold is capable of producing quality parts within Cp/CpK requirements.
Supports quoting activities by providing necessary cost card information
Support and enforce company goals and objectives, policies and procedures regarding Safety, Health and Environmental, Good Manufacturing Practices, Good Documentation Practices, FDA and ISO regulations.
Bachelor’s degree in a related technical field such as Mechanical Engineering or Plastics Engineering, advanced degree preferred.
10 years manufacturing/process development experience
5 years prior experience in medical device manufacturing preferred.
Solid knowledge of GMP, ISO regulations.
Strong applied knowledge with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.