Job Description Summary

This position is responsible for Component and Tooling Design and Process Implementation across the Medical Segment business and is positioned to ensure that the company's component design, supply, cost, etc. are aligned to business expectations. These positions provide expert engineering skill, judgement, and mentoring of other engineers. This role will oversee the planning, coordination and oversight in the development and implementation of replacement molds and related activities as well as molds to support new product development. This role will establish and maintain strong technical relationships at external vendors molding BD parts.

Job Description

We are the makers of possible

• Responsible for the design of molds/presses, responsible for user requirements specifications (URS) to ensure it meets specific manufacturing requirements.
• Provide cost input (equipment, engineering, materials).
• Manage the integration of new equipment through SAT completion, and support Equipment Integration during install and startup. Implement Process Design on new equipment and ensure product designs are being met.
• Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective collaborators.
• Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.
• Partnerships with procurement for vendor selection.
• Active participant with suppliers regarding process optimizations and continuous improvements on molding projects
• Captures process performance from sites, existing molds.
• Responsible for vendor contracts in collaboration with procurement and legal.
• Develop innovative concepts for mechanical systems and equipment based on project requirements, industry trends, and standard methodologies.
• Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.
• Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc.
• Optimize equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator's standpoint, maintainability, and ensure manufacturability.
• Participate in design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.
• Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.
• Perform various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design.
• Work closely with other engineering fields. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components.
• Support operations during a production crisis. (quality, supplier, etc.)

• Bachelor's Degree in Mechanical Engineering, Plastics Engineering or related field, or relevant equivalent experience
• 3+ years in mold design / procurement and plastics processing experience is required
• Tooling design experience of injection molds is desired
• Proficiency in SolidWorks and understanding of Mold Flow Analysis tools is desired
• Excellent technical skills including project management, organization, planning, and capital budgets relating to mold procurement and verification.
• Demonstrated ability to apply problem solving and data analysis methods.
• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.
• Experience in an FDA regulated quality environment desired.
• Willingness and ability to travel domestically and internationally up to 25%.
• Experience leading projects end to end.
• Strong communication skills
• Risk analysis / FMEA
• Statistical analysis / SPC system
• Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.