Manufacturing Engineering Manager

What we are looking for:

The Manufacturing Engineering Manager will lead the Manufacturing Engineers in focusing on expanding the manufacturing and technology capabilities, improving existing manufacturing systems, enabling the introduction of new products, and providing project management support for various departments and capital projects throughout the company.

What you will do:

• Leads the Manufacturing Engineering team to focus on process development and improvement with the product development engineering team to ensure manufacturability, minimize risks, and optimize costs associated with products.
• Evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, automation, tooling, production equipment capabilities, assembly methods, and quality control standards.
• Represents the Manufacturing Engineering team on the Site Leadership team and participates in daily visual management (Tiered daily production meetings).
• Develops new manufacturing methods using existing or new equipment to ensure repeatability, conformance to customer specifications, and cost optimization.
• Confers with vendors and internal resources to determine product specifications and arrange for purchase and installation of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Improves manufacturing systems and methods by using sound engineering practices and prioritizes initiatives to ensure customer service goals are achieved with best use of organizational resources.
• Leads the identification of process improvement opportunities and cost reduction activities with the engineers and in alignment with continuous improvement team members across the organization.
• Evaluates equipment and processes for repeatability and make improvements as necessary.
• Investigates new technologies, manufacturing methods and equipment to meet competitive business needs and improve efficiencies.
• Provides technical support to various departments in the Company and oversees the development and execution of protocols including IQ, OQ and PQ activities as required.
• Works with their team to revise documents such as Preventative Maintenance, Work Instructions, and Internal Specifications.
• Analyzes process outputs using statistical methods to ensure stability and identifies actions to improve yield performance strategically and tactfully with the engineering team and cross-functional groups.
• Interacts with suppliers and obtain quotes as necessary.
• Evaluates equipment and processes for repeatability and make improvements as necessary.
• Performs cost analysis, provide budgets, and justify capital expenditures on projects.
• Analyzes and plans work force utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency.
• Leads capital equipment expense requests for the manufacturing areas and justifications.
• Follows established safety requirements.
• Creates the department budgeting process and monitors and controls expenses through the year to meet budget requirements.
• Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.
• Provides leadership guidance and development plans for their engineering team.
• Performs other duties as required and/or assigned.

Who you are:

• Bachelor's degree with a concentration in Textile, Mechanical, Biomedical or Industrial Engineering
• A minimum of ten (10) years’ related experience in a manufacturing or process/project related engineering role, preferably in the medical device, textile or pharmaceutical industry.
• A proven track record of leading technical teams in a regulated industry.
• Strong organizational skills with exceptional time management
• Ability to manage a technical project, understanding the client’s needs, how the needs relate to the scope of the project and how changes will affect other systems.
• Excellent verbal and written communication skills
• Ability to independently prioritize and execute projects and responsibilities
• Familiar with ISO 13485 and FDA Design Control Ability to lead technical projects and participate in strategic discussions amongst peers, management, clients and/or contractors.
• Considerable knowledge of a variety of textile and/or medical device manufacturing techniques.
• Ability to travel domestically and internationally, less than 5%