Responsibilities:

Extensive knowledge of assembly and assembly related technology
Be proficient on time/motion methods and studies
Assemble effective multi-discipline core team members and effectively lead team activities
Coordinate the acquisition of data to initiate and complete improvement projects
Perform ergonomic analysis, justify, and implement improvement activities
Coordinate purchase evaluate of new / existing equipment/system from design and implementation phase to ensure proper integration with human elements and budgetary compliance including new program launches
Write & coordinate to complete validation protocols, procedures and final reports for new equipment & processes to support customer & internal requirements
Work closely with operations to ensure operators are properly trained on processes required for production of new / existing components
Evaluate material and information flow and identify areas of improvement includes creation of parts & inputting Bill of Materials (BOMs)
Interface with users of systems to identify current issues and identify/justify/coordinate improvement activities
Standardize raw material, equipment, and documents with objective of mitigating, reduction, and prevention of variation within processes
Reduce inventory loss of finished goods, purchased components and maintaining or improving inventory accuracy targets
Evaluate and implement proposed/required changes on manufacturing process related documents
Ability to design, build & modify basic fixtures or equipment, automated systems, poke yokes etc. for best practices & continuous improvement initiatives
Supports / keeps up to date with both existing & new automation technology with component & process upgrades
Performs training of technical staff to support maintain manufacturing related equipment which includes automated systems, robotic applications, programmable controllers etc.
Develop visual systems to facilitate management by Visual Management
Participates/leads proactive continual improvement efforts using multi-disciplinary teams.
Supports / participate in corrective action activities
Effectively apply PDCA (plan, do, check, action) in all aspects of job
Perform plant layout analysis by working directly with manufacturing on workplace layouts, manning requirements, material flow & processes along with various other activities (i.e., performance of time study analysis, task inventories, standard work content charts and ergonomic reviews) make recommendations, develops, and implements plans for new / existing model programs
Supports / keeps up to date with both existing & new automation technology with component & process upgrades
Performs training of technical staff to support maintain manufacturing related equipment which includes automated systems, robotic applications, programmable controllers etc.

Qualifications:
Requires a bachelor’s degree in engineering in Mechanical Engineering, Industrial Engineering or Biomedical Engineering is preferred.
A minimum of 5 years’ experience in product quality within the medical device industry is preferred.
Previous knowledge and experience in manufacturing processes of chemicals & plastics is preferred.
Computer skills including Microsoft Office and Manufacturing Management products.
Strong communication skills and works well with team members.
Strong decision-making skills & problem-solving skills.
Must be familiar with cGMP requirements.
Recommended to have experience with EPA, FDA regulations (i.e. 21 CFR 820)


Other Duties:
Please note this job description is not designed to cover or contain a comprehensive
listing of activities, duties, or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time, with or without notice.