Master's or Bachelor's degree in Engineering (Plastics or Mechanical preferred)
Six Sigma Black Belt certification is a plus
Minimum of 7 years experience in molding, micro molding, mold flow, and tooling
Hands-on experience in various technical areas, materials, and product design for at least 7 years
Current experience in medical device development within FDA-regulated environments
Responsibilities
Partner with team members and leaders to enhance injection molded and assembled products across manufacturing stages.
Create validation protocols (IQ/OQ/PQ) in compliance with FDA regulations.
Lead troubleshooting initiatives and conduct detailed root cause analyses.
Apply Lean methodologies to develop innovative technical solutions.
Take on hands-on roles where flexibility is critical and growth opportunities arise quickly.
Design effective engineering solutions using Lean principles.
Oversee debugging, packaging, and sterilization processes.
Benefits
Opportunities for rapid advancement.
Engagement in cross-functional initiatives to improve safety and quality.
Exposure to a dynamic work environment that prioritizes innovation.
Development of expertise in manufacturing processes related to FDA regulations.
Full Job Description
RESPONSIBILITIES
Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages.
Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements.
Lead troubleshooting efforts and guide the team through detailed root cause analyses.
Apply Lean methodologies to engineer inventive, comprehensive, and workable technical solutions.
Serve in a hands-on capacity where versatility is essential and advancement opportunities emerge quickly.
Leverage Lean principles to design creative, thorough, and pragmatic engineering solutions.
Oversee debugging, packaging, and sterilization activities.
Contribute to cross-functional initiatives aimed at elevating safety, quality, efficiency, and total productivity.
Track and validate current injection molding processes and tooling to identify and implement continuous improvement initiatives.
Record modifications to processes and equipment through the change management system.
Pinpoint risks, assess technical alternatives and value propositions, and advocate for optimal solutions.
REQUIRED QUALIFICATIONS
Master's or Bachelor's degree in Engineering (Plastics or Mechanical disciplines preferred)
Six Sigma Black Belt certification is a plus
A minimum of 7 years working with molding, micro molding, mold flow, mold-making, and tooling in a manufacturing setting
At least 7 years of hands-on experience spanning various technical areas, materials, manufacturing, and product design
Current experience in medical device development within an FDA-regulated (21 CFR 820) and/or ISO 13485 environment
Background in design enhancement and proficiency with SolidWorks/CAD tools
Working knowledge of statistical analysis and statistical process control
Excellent written and oral communication abilities, along with strong documentation and organizational skills
Demonstrated mechanical aptitude
A genuine enthusiasm for problem-solving, with the ability to juggle competing priorities and excel in a fast-moving workplace
