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.

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 inspect (FAI) 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 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 Job Qualifications:

• Minimum 7 years of proven experience in tooling for manufacturing environment in injection molding.
• Clear understanding of injection molding processing.
• Extensive experience in tooling design and troubleshooting.
• Experience in communicating with vendors, purchasing new equipment and injection molds.
• Minimum of 5 years related experience in an FDA/GMP regulated injection molding facility.
• Experience with measuring devices such as calipers, drop gauges, gauge blocks/pins, and comparators.
• Computer skills with MS-Office.
• Basic knowledge of Computer Aided Design Tools: AutoCAD and SolidWorks.

Preferred Job Qualifications:

• Experience providing training related to injection molding. 
• Six Sigma or Lean Six Sigma green/yellow belt.
• Extensive knowledge of the ISO/FDA requirements for medical devices.
• Bachelor’s degree in an Engineering or Science discipline or equivalent work experience.

Physical Demands:

· Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.

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

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

· Use good judgement and follow procedures.

· Work under stress in a fast-paced environment.