Job Title: Senior Manager, Engineering Plastics Processing - Extrusion
Location: Onsite - Lakewood, CO (RELOCATION Package available)
Type: Direct Hire
Salary Range: $160,000 to $200,000/year, 20% target bonus

Position Overview

The Senior Manager of Engineering Plastics Processing is responsible for leading the strategy, development, and execution of tubing extrusion, plastics processing, and plastic compounding operations. This leader directs a multidisciplinary engineering and scientific team, manages complex technical programs, ensures regulatory compliance, and supports long term business and product development objectives. The role requires deep technical knowledge, strong program and project management capabilities, and broad leadership experience within highly regulated medical device environments.

Responsibilities

Lead Extrusion and Plastics Processing Strategy and Execution
Oversee tubing quality, cost efficiency, production performance, and process optimization across the organization, ensuring operations and output align with demand.

Provide Subject Matter Expertise in Plastics Processing
Serve as a technical authority in plastic processing, partnering with cross functional teams to solve complex problems, support process development, and guide supplier qualification and engineering standards.

Manage and Develop the Engineering Function
Lead a multidisciplinary engineering team, drive strategic planning, oversee budgeting and long range planning, and ensure alignment with organizational policies, quality systems, and regulatory requirements.

Key Responsibilities

• Direct all tubing extrusion, plastics processing, and compounding initiatives, ensuring production rates, quality, and cost performance meet business requirements.

• Serve as a recognized expert in plastic processing, providing guidance to engineering teams and collaborating with other functions to optimize performance.

• Develop and implement strategies to enhance tubing extrusion, plastics processing, and compounding capabilities.

• Support qualification and oversight of external suppliers for extrusion, film production, and plastic compounding.

• Oversee the development and maintenance of engineering standards related to extrusion, film production, and compounding.

• Provide technical leadership to extrusion process engineers during process development, scale up, and validation activities.

• Manage the development, direction, and effectiveness of the functional engineering team.

• Participate in short and long term planning to establish technical priorities for the business unit or functional area.

• Use technical and managerial expertise to evaluate solutions, adaptations, and modifications to global projects and products.

• Identify and prioritize project and product opportunities, then drive implementation.

• Lead annual department budgeting and contribute to long range strategic planning.

• Interpret and implement FDA, GMP, GDP, ISO, ASTM, EMEA, and other global regulatory requirements.

• Ensure compliance with company Quality System regulations and maintain safe working practices.

• Demonstrate broad management experience and influence across multiple unrelated functions within and outside the company.

Requirements

• Minimum 10 years of progressive experience, including at least 5 years in a supervisory role.

• Deep expertise in medical device plastic processing, tubing extrusion, and plastic compounding or pelletizing.

• Extensive knowledge of program and project management methodologies.

• Comprehensive understanding of global regulations and policies including GMP, GDP, FDA, EMEA, ISO standards, and ASTM standards.

• Proven ability to lead multidisciplinary engineering and scientific teams working on multiple projects.

• Ability to balance commercial priorities with development needs to achieve global business objectives.

• Advanced knowledge of Design Controls and Quality Management Systems related to product development.

• Broad management experience and recognized subject matter expertise inside and outside the company.

• Demonstrated success collaborating with business segment, regional, and product development leaders on long term planning.

• Broad theoretical knowledge of quality, global regulatory standards, management, and manufacturing.

• Working knowledge of company products and therapeutic applications.

• Strong leadership, managerial, strategic planning, and global communication skills.

• Proven ability in planning, budgeting, associate development, and complex project management.

• Strong technology expertise and the ability to apply appropriate methods across programs.

• Proficiency with relevant PC software applications and the ability to use them effectively.

• Excellent verbal and written communication skills.

#M3

Ref: #558-Scientific