Company Summary:

Our leading medical device company, renowned for its innovative products and dominant market share, is projected to grow to a $2 billion company by 2028, and a $4 billion company over the next 10 years. We are looking for a Plastics Extrusion Engineer to operate as the SME for our Process and Product Development teams.

Responsibilities:

1. Establish cutting-edge manufacturing capabilities.
2. Develop and optimize manufacturing processes for new products.
3. Provide a comprehensive knowledge base to support manufacturing, quality, and supply chain functions.
4. Offer technical guidance to executive management for strategic decision-making.

Projects:

As a successful candidate, you will engage in ongoing projects such as:

• Developing advanced plastics formulations to enhance product performance.
• Assisting in expanding PVC film extrusion processes to access new markets.
• Improving the reliability of extruded tubing supply.

Role Overview:

As a successful candidate, you will:

• Become the primary expert in polymer chemistry and plastics extrusion on a global scale.
• Define and develop manufacturing processes and the equipment necessary for them.
• Collaborate on cross-functional teams to innovate manufacturing processes alongside new product development.
• Provide design-for-manufacturability insights to concurrent engineering teams.
• Integrate your expertise with that of other SMEs to enable successful manufacturing systems.
• Guide and support capital project teams in integrating processes into global manufacturing systems.
• Define critical process parameters, monitoring, and validation methods to ensure the successful implementation of processing equipment.
• Act as an SME to train others and support manufacturing capabilities within your expertise.
• Provide on-site support to manufacturing sites in Costa Rica, India, Vietnam, and Northern Ireland, with potential international travel for project support.

Essential Duties:

• Independently evaluate, select, and adapt project modifications.
• Lead significant portions of major projects and manage smaller projects entirely.
• Contribute to the group's development, aligning with organizational policies and business objectives.
• Implement and understand FDA or regulatory requirements as needed.
• Apply technology principles across various tasks.
• Develop knowledge of cross-functional and related technical areas.
• Complete tasks efficiently, highlighting risks to optimize time and resource expenditure.
• Proactively advise team members on technical ideas and promote teamwork skill development.
• Secure resources and commitments by interacting with peers across projects.
• Manage frequent inter-organizational and supplier contacts.
• Represent the organization in resolving complex technical issues related to projects.
• Develop and follow technical specifications, providing feedback on processes and procedures.
• Present complex technical information effectively and respond to questions from technical staff and management.
• Work cooperatively within a team environment to achieve common goals, often influencing team outcomes.
• Provide work direction to technicians and junior engineers.
• Collaborate with manufacturing and other functional groups on compliance issues.

Education:

• A Bachelor's degree or equivalent education and experience sufficient to successfully perform the job's essential functions may be considered.
• Preferred: Bachelor of Science or Master of Science degree in Engineering.

Experience:

• At least 8 years of experience in related fields.
• Minimum of 2 years' experience in GMP manufacturing required.