Senior Manager, Engineering Plastics Processing

Title- Senior Manager, Engineering Plastics Processing 

LOCATION - Lakewood, Colorado- Open to candidates willing to relocate to the area. Full time

TRAVEL - Must be willing and able to travel up to 50%, including international travel.

Description

As the leader of the client Program, you'll drive innovation in medical device plastic processing. In this high-impact role, you’ll oversee tubing extrusion, plastic compounding, and supplier qualifications while collaborating with cross-functional teams to enhance quality, efficiency, and performance. With a strong focus on technical leadership, strategic planning, and regulatory compliance, this position offers the opportunity to shape global processes and mentor engineering teams. If you’re an expert in medical device plastics with a passion for innovation and leadership, we invite you to bring your expertise to our dynamic and growing team in Lakewood, Colorado.

ESSENTIAL DUTIES

Lead the Client Extrusion Vertical Integration Program, ensuring tubing quality, cost efficiency, and production rates align with demand.

Serve as a Subject Matter Expert in plastic processing, collaborating with cross-functional teams to optimize performance.

Develop and implement strategies to enhance tubing extrusion and plastics processing.

Support the qualification of external suppliers for tubing extrusion, film production, and plastic compounding.

Oversee engineering standards for tubing extrusion, film production, and plastic compounding.

Provide technical leadership to extrusion process engineers during process development phases.

Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

Participates in the short and long term planning process that establishes technical objectives for a business unit project or functional engineering group.

Utilizes technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to projects and products used globally.

Identifies project, product opportunities and initiates prioritization in addition to implementation.

Completes annual department budgeting and accountable for long range planning.

Implements and understands FDA or global regulatory requirements as necessary.

Ensures compliance with company Quality System regulations and safe working practices.

Demonstrates broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in Mechanical Engineering, Manufacturing, Biomedical Engineering, or a related field; a Master's degree is also acceptable.

Experience

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

Extensive experience with program and project management methodologies.

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

Comprehensive knowledge of regulations, policies, and global pharmacopoeia, including EMEA, GDP, GMP, FDA guidelines, ISO standards, and ASTM standards.

Skills

Demonstrated ability to lead a multi-discipline engineering and scientific team working on multiple projects.

Skilled ability to balance commercial and development needs to accomplish global business area goals.

Advanced understanding and application of Design Controls, Quality Management System to product development.

Broad management experience across and recognized as an expert within and outside of the Company with fully developed leadership skills and a deep understanding of a broad issues vital to the company working with multiple functions that are unrelated.

Work collaboratively with business segment, regional and functional product development leaders to establish long term goals for the product development team.

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

Requires working knowledge of the business's products and therapeutic uses.

Effective leadership, managerial, and strategic planning and global skills.

Exceptional demonstrated expertise in planning, budgeting, associate development, and project management directed toward achievement of annual, long term, and strategic business plans and goals.

Requires an exceptional understanding of technology and methods applicable to the area and the ability to determine appropriate application.

Knowledge and use of relevant PC software applications and skills to use them effectively.

Demonstrated ability to communicate effectively both verbally and in writing.

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