WORKING CONDITIONS:

• Works with supervision from manager as necessary. Requires light physical activity performing non-strenuous daily activities, as well as some work with tooling.
  The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

o 3-7 years industry experience

• Demonstrated history to problem solve, identify errors and deficiencies and perform research
• High degree of understanding of ISO 13485 requirements Medical Device Industry
• Ability to provide guidelines and instructions applicable to the job function
• Accuracy, attention to detail, and thoroughness
• Proficient computer skills
• Proficient communications skills
• Ability to comprehend and comply with company safety and quality standards
• Ability to provide oral and written instructions to other

JOB PURPOSE:

• To make design changes or improvements to existing extrusions. Including support of extrusion process, tooling design, assembly, maintenance, outsourcing, and insoucing.

ESSENTIAL DUTIES:

• Extrusion Manufacturing Area:
  o Maximizes productivity, whether equipment, work force utilization, workstation optimization, administrative systems, and internal supply chains.
  o Leads internal initiatives for continuous improvement, such as implementation of Lean Manufacturing principles.
  o Provides on-demand support on manufacturing floor for issues that may require timely resolution and executes on plans to reduce recurrence
  o Able to identify and implement process changes and systems that need improvement
  o Key contributor to Kaizen events identified for immediate impact on product lines and specific manufacturing processes or systems

o Addresses major issues found through exception events (such as non-conformances, temporary deviations, etc.) through the identification of root cause and corrective action

• Upholds Spectrum Plastics Group vision and core values
• Follows all safety guidelines and adheres to safety absolutes

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

• Bachelor’s degree in engineering or equivalent experience in a related field.

o 3-7 years industry experience

• Demonstrated history to problem solve, identify errors and deficiencies and perform research
• High degree of understanding of ISO 13485 requirements Medical Device Industry
• Ability to provide guidelines and instructions applicable to the job function
• Accuracy, attention to detail, and thoroughness
• Proficient computer skills
• Proficient communications skills
• Ability to comprehend and comply with company safety and quality standards
• Ability to provide oral and written instructions to others

Preferred:

• Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion
• Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
• Has knowledge of commonly-used concepts, practices, and procedures within medical device design and development

o Techinical report writing
o Validation experience with IQ/OQ/PQ

o Root Cause Analysis

• Can handle financial responsibilities for project such as budget accountability and revenue recognition
• Demonstrated ability to complete product commercialization