Engineer II – Molding Process

Role Overview

• Work with project teams to identify issues and risks.
• During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
• Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
• Lead/support process improvement initiative.
• Introduce new equipment, products, and processes.
• Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation.
• Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
• Develop an understanding of the current manufacturing processes and identify targets for improvement in operation efficiencies.
• Develop manufacturing Work Instructions.
• Provide process support on manufacturing technical issues.
• Provide process and equipment expertise and support for daily clean-room sterile packaging efforts/and or production efforts.
• Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
• Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
• Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
• Develop protocols and coordinate validation of equipment and processes.
• Stay current with methods used in the medical device industry to advance technologies.
• Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities. Investigates and test in time reliability and quality improvements
• Drives automation to replace the manual process as much as possible
• Ensure Information and documentation is consistently accurate
• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Applies statistical methods to estimate future manufacturing requirements and potential. Provide process and equipment expertise and support.
• Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.

Requirements

• Bachelor’s degree in Engineering required.
• 2 years of manufacturing process improvement experience required.
• Proven experience in leading process improvement projects.
• Medical device manufacturing environment preferred.
• Experience in workflow optimization, work measurement, efficiencies.
• Recognized process improvement training (Lean, Six Sigma) preferred.
• Ability to work independently and effectively with cross functional teams.
• Thorough understanding of manufacturing processes.
• Detail oriented with strong analytical skills.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Experienced user of MS Office Suite and CAD.
• Experience with planning and conducting tests to validate equipment and processes.
• Experience in completing technical documentation for engineering and manufacturing.
• SPC (Statistical Process Control) knowledge.
• Familiarity with clean room practices preferred.
• Project management knowledge preferred.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)