Engineering Lead

Jobtailor; Illinois; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in Illinois seeks a Senior Engineer to lead supplier qualification and injection molding process optimization, driving scale-up and cross-functional teams.

You will oversee mold tool design, stamping tooling, FAI analysis and regulatory compliance in CGMP/FDA environments, traveling up to 15%.

Qualifications

• Bachelor’s Degree in engineering, science, or closely related discipline is desired, or equivalent technical experience.
• 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.

Responsibilities

• 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.

Skills

Injection Molding

Tool Design

First Article Inspection

Design of Experiments

Statistical Analysis

Tolerance Stack Analysis

Education

Bachelor's Degree in Engineering or related

Tools

RJG Pressure Transducers

Molding Machines

Coil Handling Systems

Progressive Dies

Job description

• 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.

Requirements

• 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.

Core Competencies

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.

Highest-signal resume keywords

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

Hard Skills

• 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

Soft Skills

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

Certifications & Qualifications

• Master Molder Level Qualification

Industry Keywords

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

Tools & Technologies

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