Job Description

Overview

Apply engineering knowledge to plan, develop, validate, and test manufacturing processes to meet FDA and ISO requirements. Qualify parts, equipment, fixtures, test plans to guarantee adherence to customer and regulatory requirements.

• Review criteria with potential suppliers and support the development of quotes for parts, fixtures, and equipment.
• Coordinate equipment installations with Facilities and/or manufacturing departments.
• Monitor the status of projects including equipment and process qualifications, change orders, and product launches.
• Establish project plans and provide feedback to appropriate personnel.
• Analyze production data to identify trends and develop appropriate action items.
• Lead customer and supplier technical communications.
• Research sources for domestic and international parts.
• Participate / create Design of Experiments and test method validations (Gage R&R).

Qualifications

• Bachelor’s degree in Engineering or related field and 2-5 years’ experience in a manufacturing environment or related field.
• Experience in medical devices industry or equivalent regulated industries
  – ISO13485
  – FDA 21CFR
  – GMP/GDP
• Proficient in Microsoft Office.
• Strong written and verbal communication skills.
• Ability to create and verbally deliver presentations to internal management and other audiences.
• Requires analytical, problem solving and project management skills.

How to Apply

Job Categories: Engineering And Architecture. Job Types: Full-Time. Salaries: 60,000 - 80,000.

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