Engineering Lead, Manufacturing Engineer, Process Engineer

• Manage and maintain the technical qualification of injection molding component suppliers and supplier processes.
• Supervise resolution of complex technical issues and lead the supplier development team for designated components and processes.
• Provide technical support and expertise for molding process optimization, molding validation and tool design to custom part suppliers and team members.
• Drive supplier activities from production start-up through scale-up to increased volumes within ADC requirements.
• Lead large-scale, complex, multiple projects.
• Coordinate and lead internal and external resources to achieve project goals.
• Facilitate design/specification, purchase, installation and qualification of injection mold tools, molding machines, ancillary equipment and services.
• Facilitate design/specification, purchase, installation and qualification of reel-to-reel progressive stamping and forming tooling, including strip layout design, feed systems and in-die sensing.
• Provide technical leadership in molding process characterization, SIM studies and validation activities.
• Support suppliers in qualifying new and existing molds, optimizing processes and resolving technical issues.
• Identify, characterize and document key process variables included in Design Transfer.
• Optimize supplier manufacturing processes through capital projects, statistical analysis, design of experiments and procedural changes.
• Lead or participate in cross-functional teams supporting organizational goals.
• Serve as subject matter expert or independent technical expert on project technical matters and interface with senior management, external firms or agencies.
• Complete documentation according to business standards and comply with EHS, Corporate, divisional, GMP and applicable regulatory policies.

• Bachelor’s Degree in engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
• Strong understanding of injection molding process and tool design.
• Expertise in stamping, strip metal forming, coil fed manufacturing environment and reel-to-reel progressive dies is preferable.
• Experience with die design fundamentals, blank development, spring-back compensation and tolerance stack analysis.
• Knowledge of stamping press selection and coil handling systems.
• Experience qualifying stamping tooling through FAI, capability studies and tool transfer methods.
• Prior experience analyzing First Article Inspection (FAI) and PpK data.
• Familiarity with cGMP, FDA and ISO regulated environment.
• Experience working with tooling manufacturing sites, toolmakers and equipment suppliers for design, FOT and FAT qualification activities.
• Equipment design and specification with validation experience.
• Design of Experiment for plastic injection molding process development.
• Strong technical knowledge and application of concepts, practices, and procedures.
• Ability to work on complex problems involving multiple competing factors.
• Ability to work independently, in groups and cross-functionally.
• Demonstrated initiative, problem-solving and critical-thinking skills.
• Ability to use various databases and computer software.
• Strong organizational and project management skills.
• Ability and aptitude to quickly gain knowledge, understanding or skills and willingness to learn.
• Technical project management experience in injection molding industry, preferably medical molding.
• Experience working with third-party molders for complex parts.
• Qualification in Injection Molding Process development SIM study to Master Molder level would be an advantage.
• Experience with RJG pressure transducers for process control would be an advantage.
• Ability to travel approximately 15%, including internationally.

Demonstrates expertise in injection molding process optimization, tool design, and supplier qualification, with a strong focus on project management and cross-functional collaboration. Proficient in statistical analysis and design of experiments to enhance manufacturing processes in regulated environments.

• Injection Molding Process Optimization
• Tool Design Expertise
• Project Management in Injection Molding
• Statistical Analysis and Design of Experiments
• CGMP and FDA Compliance

• Injection Molding Process
• Tool Design
• Stamping Tooling Qualification
• First Article Inspection (FAI)
• Design of Experiments
• Statistical Analysis
• Tolerance Stack Analysis
• Process Characterization
• Equipment Design and Specification
• Project Management

• Problem-Solving
• Critical Thinking
• Initiative
• Organizational Skills
• Ability to Work Cross-Functionally

• Master Molder Level Qualification

• CGMP
• FDA
• ISO
• Injection Molding
• Stamping
• Coil Fed Manufacturing
• Design Transfer
• Toolmakers
• FOT and FAT Qualification
• Medical Molding

• RJG Pressure Transducers
• Molding Machines
• Ancillary Equipment
• Coil Handling Systems
• Reel-to-Reel Progressive Dies