MS or B.S. in Engineering (Plastics or Mechanical preferred) or equivalent experience
Six Sigma Black Belt certification is a plus
2+ years in molding, mold-making and tooling within a manufacturing context
2+ years in various technical, material science, manufacturing and product design roles
2+ years of CAD experience
Familiarity with statistical analysis and process control
Electromechanical experience required
Recent work in an FDA regulated (21 CFR 820) and/or ISO 13485 environment
Strong communication and organizational skills
Responsibilities
Coordinate production and engineering teams across various manufacturing processes
Collaborate with colleagues and management to enhance injection molded and assembled products
Assist in process and product monitoring, creating validation protocols (IQ, OQ, PQ) to meet FDA standards
Guide troubleshooting efforts and conduct root cause analysis to address manufacturing issues
Apply Lean principles to devise innovative and practical technical solutions
Engage in hands-on work within a rapidly growing organization
Embrace opportunities for professional growth and development
Benefits
Dynamic work environment with a focus on innovation
Opportunity to work with cutting-edge technologies in healthcare
Hands-on role allowing for direct impact on product development
Collaborative team culture fostering skill development
Growth potential in a rapidly expanding company
Full Job Description
DUTIES
Coordinate a production and Engineering Team in a variety of manufacturing processes.
Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations.
Provide troubleshooting focus and direction for the team with details of root cause analysis.
Utilizes Lean principles to develop creative, thorough and practical technical solutions.
This is a hands-on position in a growing organization and an opportunity which will grow rapidly.
QUALIFICATIONS
MS. or B.S. in Engineering (Plastics or Mechanical preferred) or equivalent experience.
Six Sigma Black Belt, a plus.
2+ years of experience in molding, mold-making and tooling in manufacturing environment.
2+ years of experience in diverse technical, materials, manufacturing and product design.
2+ years of experience with CAD.
Understanding of statistical analysis and statistical process control.
Electromechanical experience is required.
Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment.
