Primary Duties & Responsibilities:

• Complete technical supplier assessment, identify actions and develop plans to improve suppliers' manufacturing capability for machinery, tooling and processes, quality, workforce, capacity, continuous improvement and sub-tier management.
• Understanding the manufacturing industry to assist with sourcing decisions regarding key contract manufacturing
• Investigating and evaluating new and existing technologies to improve the quality and reliability for current and future products
• Review and develop supplier capacity analysis and tools.
• Deploy risk mitigation plans and be accountable for decreasing supplier risk
• Facilitate and champion continuous improvement events and initiatives
• Investigate problems and implement solutions to improve product quality and performance
• Drive and develop supplier problem solving techniques for identified supplier issues
• Set focused priorities to reach objectives by developing a robust mitigation action plan
• Function as liaison between sourcing, quality, design, and contract manufacturer to resolve supplier quality issues and to provide technical support
• Enhances and utilizes metrics to identify opportunities; improving product performance and reliability; component obsolescence, increasing capacity and process capability; reducing lead-times, scrap, rework, and operating costs; enhancing customer experiences; and meeting our commitments:
  • Uses data, product application, and sound engineering judgement to make decisions
  • Uses appropriate problem solving and continuous improvement tools
  • Develops, maintains, and communicates project plans, and coordinates project activities
• Works as an integral member of new product development teams, helps to define requirements, performs process qualifications, identifies suppliers and ensures products are manufacturable
  • Ensures new product designs are manufacturable, and processes are capable
• Performs work in accordance with Regulatory Requirements (i.e. FDA, MDR, UL, CE and other governing bodies) and Quality Management System (QMS), including development and maintenance of documentation.

Qualifications (Knowledge, Skills & Abilities):

Minimum

• B.S. in Engineering
• Strong problem-solving and critical thinking skills
• Proven understanding of manufacturing problem solving, data analysis, and production flow tools
• Assertive self-starter with excellent organizational, interpersonal, critical thinking, verbal and written communication skills
• Ability to travel up to 20%

Preferred:

• Experience working with medical device contract manufacturers
• Knowledge of how to properly analyze data sets using statistical software ( i.e. Minitab, JMP, LabVIEW, etc.)
• Technical project management skills
• Experience in process development and process improvement