NPI Production Supervisor - IPG

Description

The NPI Production Supervisor will supervise and coordinate all the activities for the active implantable pilot line NPI Operators and associated project builds at Resolution Medical. The active implantable products are for fully implantable medical devices, so take place in FDA certified clean rooms requiring appropriate gowning and PPE wear. This person will be responsible for supporting and managing the production employees and ensuring products are produced in accordance with SOPs and WIs as well as ensuring OTD and attainment is met.

This person will drive success within product lines, as well as facilitate smooth development and transfer of multiple projects.

• Set standards and monitor staff performance, provide performance feedback, and provide coaching to the NPI Pilot Line team
• Responsible for production personnel management, hiring, and staffing needs
• Communicate with support functions on resource needs and project improvements
• Prioritize production schedules based on product introduction, equipment efficiency, and materials supply
• Create and update documentation for production lines
• Ability to leverage continuous improvement tools to identify and execute process improvement opportunities
• Lead line balancing and continuous improvement of production lines
• Promote an environment of employee empowerment, teamwork, continuous improvement through lean principles, compliance, quality, personal growth and development
• Lead tier meetings to facilitate communication and problem solving between support team members
• Identify opportunities for productivity, business, and quality improvements
• Follow company policies and procedures
• Support production output, customer demands and quality initiatives.
• Read and analyze charts, work orders, production schedules and other records and reports to determine production requirements and to evaluate current production estimates and outputs
• Accurately complete all essential documents (Manufacturing Procedures, Device Master Records, Validation Documentation)
• Facilitate communication between operators and technical team to ensure issues impacting yield and efficiency are addresses promptly
• Plan production resources
• Identify opportunities for productivity, business and quality improvements
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

• Bachelor’s degree and/or 6 + years of experience working in medical device or equivalent combination of education and experience.
• 4 + years’ experience supervising manufacturing or pilot line operations at a medical device company.
• Must have experience in analyzing and solving problems in a timely manner, successfully multitasking and prioritizing and using critical thinking and reasoning skills.
• Knowledge of quality system and understanding of CAPA system
• Demonstrated success in error resolution, conflict management, and working in a team environment
• Experience in a medical device manufacturing environment, and ability to work around lasers, soldering, assembly, and electronics.

• Ability to handle and be trusted with confidential and/or sensitive information.
• Ability to work in a fast-paced, constantly changing environment.
• Ability to frequently sit, stand, walk, reach with hands and arm’s length, climb or balance, kneel, and crouch
• Prolonged periods of sitting at a desk and working on a computer and/or microscope
• Must be able to lift up to 25 pounds at times
• Must have excellent hand-eye coordination
• Ability to differentiate between colored wires, tabs, and electronic components
• Must wear gown, gloves, and ESD reductive equipment
• Must be willing to work in lab and clean room environments to support project work

• Group health & welfare benefits:
  Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits:
  Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira…