Sr. Manufacturing Engineer

Full-time - Senior

Billerica, MA

Miscellaneous Manufacturing

About the position

This Senior Manufacturing position will have a hands-on role managing and developing manufacturing processes for innovative single-use medical devices for therapeutic applications. The position offers the unique opportunity to partake in an early-stage start-up company with career advancement opportunities. The right individual has process development, project management, and manufacturing experience, and is eager to face engineering challenges and participate in ongoing facility and equipment improvements.

Responsibilities

• Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing products, and in support of business development initiatives with customers creating new products
• Lead verification and validation exercises to support the launch of commercial manufacturing.
• Lead efforts to address non-conformances through the NCR/CAPA system - driving escalation when risk level warrants it
• Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency
• Establish standard work and standard equipment operating parameters
• Work with the product development team to design manufacturing tooling and fixtures
• Develop and implement automation solutions
• Troubleshoot equipment problems and develop corrective actions
• Develop and execute program to reduce manufacturing costs and scrap rate.
• Analyze quality problems and develop solutions and improvements
• Work with Quality Control to resolve supplier quality issues
• Develop capital equipment proposals
• Responsible for achieving device manufacturing and engineering (M&E) operational objectives in support of process validation, clinical trial execution, product launch, quality, cost and safety.
• Delegate project tasks based on development staff members' individual strengths, skill sets and experience levels
• Track and drive project performance, specifically to analyze the successful completion of short- and long-term goals.
• Meet budgetary objectives and make adjustments to project constraints based on financial analysis
• Develop comprehensive project plans and manage the execution of the plan. Must be able to present project plans and timeline to cross functional team.

Requirements

• BS in Manufacturing, Mechanical, Industrial or Plastics Engineering
• 8+ years' experience in an equipment intensive ISO 9000 manufacturing environment
• Project management experience is Required
• Proficient with SolidWorks, with a demonstrated ability to design fixtures and tooling is preferred
• Experience with plastics processing (extrusion, injection molding, fiber forming) is a plus
• Exposure to ISO 13485 standards is a plus
• Demonstrated ability to stay organized and implement organizational skills into their team members
• Strong verbal and written communication skills is essential
• Ability to respond to changing priorities and to multi-task, in a dynamic environment

Nice-to-haves

• Experience with plastics processing (extrusion, injection molding, fiber forming) is a plus
• Exposure to ISO 13485 standards is a plus