Senior Manufacturing Engineer (Molding / Tool Room)

Applies aspects of subject matter expert knowledge and experience in the identified discipline of engineering. Senior level position responsible for proactively recommending solutions and projects to management within departmental objectives. Capable of leading a project team and supervising other engineers and technicians. Provides input to budget and resource allocation without direct hire/fire responsibility. Measured against performance plan goals and objectives. Responsible for functional performance when applicable.

This role provides direct management of machinists, tool makers and technicians and is responsible for supporting the production and engineering departments with tooling for molds, dies, assembly fixtures, automation components, spare parts, and prototypes. This position supports internally fabricated tooling as well as manages external suppliers used to build molds, dies, and other tooling. This requires overall coordination of production, scheduling, health and safety, quality assurance, coaching and development, and continuous improvement activities within the tool room, while complying with policies, regulations and values for safety, quality, environmental and financial standards.

Essential Duties and Responsibilities:

· Participate in the design, development, implementation, and maintenance of tools, dies, molds, jigs, and fixtures for manufacturing processes.

· Work closely with production and product development teams to ensure that the tooling is efficient, cost-effective, and meets quality standards.

· Provide technical expertise and manufacturing support to the injection molding department (IMO) in the evaluation of proposed medical device designs for manufacturability.

· Assist in the development of capital equipment budget including but not limited to injection molding machines, molds, and accessory equipment to support long term growth.

· Provide technical advice related to plastic component material selection and part design to achieve required cost, performance, and quality requirements for new products as defined per the product development roadmap.

· Quote, select, develop, and assign the inspection (FAI) of molds for injection molding.

· Responsible for scheduling all injection molding repairs to ensure lead times are achieved.

· Recommend materials for tool production based on durability, cost, and function.

· Maintain injection molding tools and equipment in a required state of readiness as defined by management to meet the requirements of product development, manufacturing, quality assurance and regulatory.

· Participate in R&D product development, supplier selection and development activities.

· Evaluate and interpret engineering drawings and specifications.

· Train tool room staff on correct use of tooling equipment and safety procedures.

· Coordinate with tool manufacturers and vendors for tool procurement.

· Provide direction and guidance on maintenance and repair activities on tools to ensure longevity and functionality.

· Support assembly packaging operations (APO) equipment troubleshooting and repairs as requested.

· Comply with policies, regulations and values for safety, quality, environmental and financial standards.

· Performs other duties as required.

Required Qualifications:

· Bachelor’s degree or higher in any engineering discipline (preferably mechanical, industrial, or biomedical).

· 7 years of proven experience in tooling for manufacturing environment in injection molding experience with demonstrated leadership and management expertise and success.

· Minimum of 5 years of related experience in an FDA/GMP regulated injection molding facility.

· Clear understanding of injection molding processing.

· Extensive experience in tooling design and troubleshooting.

· Experience in communicating with vendors, purchasing new equipment and injection molds.

· Experience with measuring devices such as calipers, drop gauges, gauge blocks/pins, and comparators.

· Ability to interpret and direct work from CAD models, blueprints, and sketches.

· Basic knowledge of computer aided design tools: AutoCAD and SolidWorks.

· Computer skills, including MS Office.

Preferred Qualifications:

· Supervisory experience.

· Experience providing training related to injection molding.

· Ultrasonic welding experience.

· Experience with ERP.

· Process improvements experience.

Physical / Mental Demands:

· The job is performed indoors in a variety of settings including office, manufacturing floor and warehouse with no abnormal hazards or risks. Protective safety clothing may occasionally be required including appropriate dress code: no makeup or jewelry, shoe coverings, gloves, hair net, and lab coat as needed.

· Work may require weekend and evening work.

· Work may require travel.

· Physical activity includes sitting, walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 pounds.

· Work under stress in a fast-paced environment.

· Must be alert, able to concentrate, and use good judgment.

· Must be able to drive an automobile for short and long distances.