MAIN PURPOSE OF JOB

Works closely with Manufacturing Engineers and Manufacturing to support and improve manufacturing operations, including troubleshooting equipment, process issues, documenting fixtures, and updating process documentation. With guidance from a Manufacturing Engineer complete projects including fixture & process development, process validations, and continuous improvement activities.

MAIN JOB RESPONSIBILITIES

Production

• Front line for responding and troubleshooting processing, scrap, or yield issues on the manufacturing floor in support of build schedules and On Time Delivery.
• Responds to line calls in a professional, safe, and timely manner.
• Identifies, leads, and supports associates with continuous improvement activities.
• Documents results of testing and/or trouble shooting.
• Identifies and improves safety issues within the production areas.
• Maintains and improves 5S throughout assigned work areas.
• Follows and guides others on required lock out/tag out procedures and all other safety requirements.
• Prepares and sets up equipment in partnership with Manufacturing Engineers and Maintenance.
• Engages in Value Stream structure and process to support the Value Streams.
• Sustains the daily operation of production machines and fixtures with goal of zero downtime.
• Monitors the clean rooms for needed equipment repairs and submits work orders as needed.
• Consults and offers collaboration with Maintenance Technicians, Engineers and Operators to identify and resolve all equipment issues within a timely manner.
• Able to troubleshoot non-routine issues with equipment.
• Can train others on routine engineering tasks for the lines they support.
• Provides guidance/support to production within their responsibilities.
• Can independently recognize and correct errors in execution of an established process.

Engineering

• Able to support Manufacturing Engineers in the development of processes including equipment specification, fixture design and development, installation, testing, debugging, and troubleshooting.
• Able to generate and perform simple installation qualifications of equipment, fixtures, or tooling (IQ) including documenting results accurately.
• Assists Engineers with validation documentation and execution including OQ’s, PQ’s, and DOE’s.
• Assist Quality with NCR investigation support of discrepant materials.
• Support the Lead of a Corrective and Preventative Action (CAPA). Follow problem solving methodology and use of Root Cause Analysis (RCA) tools.

Other

• Follows all GMP and SOP’s as defined by Viant policies, practices, and procedures to ensure that FDA and ISO regulations and quality standards are met.
• Assist in communication with suppliers, equipment builders, or customers as required to resolve equipment issues.
• Performs other duties as assigned.

POSITION REQUIREMENTS

Knowledge/Education:

• Associate Degree in Engineering Technology or related field or equivalent combination of education and experience.
• Advance technical training or certification preferred.

Job Experience

• 4 to 6 years’ experience as a technician or equivalent combination of education and experience.
• Hands-on technical experience working within a manufacturing environment preferred.
• Previous experience in a medical device-manufacturing environment or related industry preferred.
• Ability to read, understand, and create engineering drawings, including dimensions and tolerances.
• Understanding of electrical motors, servo motors, and PLC controls. 

Skills/Competencies

• Positive teamwork attitude.
• Excellent internal customer service skills.
• Excellent mechanical aptitude.
• Good problem-solving skills.
• Proficient writing and verbal skills.
• Ability to follow both verbal and written technical instructions.
• Understanding of Lean Manufacturing philosophies.
• Experience using Excel spreadsheets and database software.
• Basic understanding of CAD software.
• Great Communication Skills.
• Basic understanding of Statistical Analysis.

Physical Requirements

• Must be able to get underneath or mount equipment ranging from floor level to elevated heights, and in confined spaces to perform repairs and inspections.
• Must be able to lift, tighten (“torque”) equipment. Frequent amounts of finger dexterity used.
• Occasional lifting up to 50 pounds. Occasional amounts of overhead lifting.
• Extended periods of standing, bending, twisting, turning.
• Must be able and willing to wear personal protective equipment as required including:
  • Protective eye ware
  • Ear plugs
  • Hair net
  • Protective gowning (lab coat, hood, shoe covers)

BENEFITS

• Medical, dental, and vision benefits-effective on date of hire
• Generous paid time off benefits and 10 paid Holidays
• 136 hours of PTO
• Company-paid life insurance
• 401k plan with company match
• Up to $150-off your gym membership annually
• Employee Discount Program with savings on electronics, home goods, gym equipment, and more