Product Development Manufacturing Supervisor

Job Summary

The Product Development (PD) Pilot Line supports PD projects from feasibility through design verification (DV) and transfer into production. In collaboration with PD, the PD Pilot Line is responsible for iterating on protype designs throughout the development process as well as larger scale builds on a stable design for DV activities. The PD Pilot Line Manufacturing Supervisor will be responsible for managing build schedules and daily operations of PD Pilot Line areas, as well as managing (supervising, directing, mentoring, motivating, training, etc.) a small team of direct reports. 

The PD Pilot Line Manufacturing Supervisor will partner with Product Development and Manufacturing leadership in order to meet Company goals for safety, quality, and productivity. In addition, this role is responsible for ensuring product traceability and engineering specifications meet the needs of the development activities and supporting the transition of NPD Pilot line process/equipment into production for commercial distribution. 
 

Job Details/Responsibilities

• Associate is responsible to follow requirements of applicable national and international regulations
• Oversees the day-to-day operations of the Pilot Line areas (i.e. daily interaction and communication of staff, setting goals and objectives, planning schedules, preventative maintenance/maintenance repair, tracking production results, etc.)
• Provides a safe work environment and resolves any safety issues that arise
• Provides training, support, and motivation to staff
• Continually improves product quality through analyzing, identifying, and eliminating root causes and implementing a corrective action (i.e. increase running efficiency, increase yield rates to reduce waste and improve outputs, 100 percent attainment of production, schedule, etc.)
• Coordinates and interacts daily with support groups
• Maintains expenses within budget
• Maintains proper raw material inventory levels required to meet the build needs
• Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, and change control practices. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the TMC Quality System and Terumo’s policies
• Participates in project performance team meetings in order to provide ideas, methods, or processes for performance improvement
• Participates in project and department meetings weekly and monthly, as needed. 
• Effectively communicate and coordinate activities to align with PMO, Engineering, Quality Assurance, Purchasing, PDC, Human Resources, Accounting/EDP, etc.  
   

Job Responsibilities (continued)

• Follow all established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
• Will supervise a team of hourly production associates, which includes recommendations for discipline, termination, evaluations, etc.
• Performs other job-related duties assigned

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Ability to direct and motivate staff
• Strong organizational skills
• Strong communication skills both verbal and written
• General knowledge of GMP requirements and ISO standards
• Some prior exposure to safety issues and good manufacturing practices
• Ability to solve problems daily regarding safety, quality, and productivity 
• Ability to make decisions based on available production knowledge, maintenance and improvement plans, etc.
• Ability to work with hand tools and perform mechanical and minor electrical duties where knowledge of the task can be learned on the job.  
• Makes production set-ups, changeovers to different products’ operations, adjustments and simple machine repairs to facilitate production.   
• May be required to drive a forklift at certain times.
• Considerable standing, walking, lifting, etc. 
• Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook 

Qualifications/ Background Experiences

• High School diploma required, with advanced education preferred.
• Minimum of 4 years’ experience in manufacturing environment, which should include a minimum of 2 years’ experience in medical device or other similar regulated industry
• Minimum of 2-3 years supervisory experience preferred
• Supervisory experience in medical device or other similar regulated industry preferred
• Project Management experience preferred