Job Description

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This position, reporting to the Vice President of Manufacturing, will have responsibilities in the following areas: Manufacturing Engineering, Facilities/Industrial Engineering, Equipment Engineering, and Product Packaging. The position will work with both development and production for the development, transfer, maintenance, and improvement of production processes and equipment for products in accordance with the company's Quality Systems. This position will have responsibility for improving process control, product quality and production costs

Primary Responsibilities:

Quality:

Partner with Quality on initiating and managing Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA) as required to address quality issues.

Manufacturing/Process Engineering:

Support production in efforts for improving process capabilities, improving product manufacturability, and reducing production costs. Work directly with suppliers to ensure on going yield, product availability, and cost targets are achieved. Provide adequate process documentation. Interface with Development in the transfer of products and processes.

Facilities/Industrial Engineering

: Assist in enhancements to production facility, including installation of equipment, production lay out, and material flow.

Manufacturability

: Work with development staff to design new products or product enhancements in a cost effective and timely manner and with an understanding of how the product will be manufactured. May be required to lead or contribute to the process of transferring product from development to manufacturing.

Supervision

: May be required to lead or train Technicians and/or Assemblers in the Operations group.

Knowledge, Skills, and Experience:

BS in Engineering or related discipline or equivalent experience.

5-7 years in medical device manufacturing, process development or design.

Knowledge and/or experience in Project Management/Planning in Medical device or related industry.

Experience working under quality systems designed to meet governmental regulations such as GMP's, ISO 9001, and the MDD

Excellent communications skills (both written and verbal) required.

Ability to work independently or in team setting required.

Must be able to travel extensively.

Requirements:

Bachelor's Degree Authorized to work in the United States 5+ years of Medical Equipment Manufacturing experience
Job Type: Full-time

Pay: $150,000.00 - $175,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance
Work Location: In person