Product Engineer Job at FPC of Huntsville
High Level Statement of the Role
The Product Engineer will provide support and best practices for manufacturing services while helping maintain compliance with FDA regulations for medical devices
Responsibilities
Product Engineer
- Leads New Product Introduction (NPI) activities
- Prepares Non-Recurring Engineering (NRE) labor and tooling estimates for new quotes, as required
- Responsible for processing DFM requests using Valor and Silicon Expert software
- Ensure compliance to the Quality Management Systems (QMS) within the facility including FDA 21 CFR 820
- Prepares detailed reports, flow diagrams, charts and other documentation by collecting, analyzing, and summarizing production data and trends
- Leads or Participates in Continuous Improvement initiatives using the 6-sigma DMAIC process
- Recommends and leads change initiatives in manufacturing methods and/or techniques, systems, and procedures to reduce manufacturing costs
- Works closely with Production Supervisors and Quality Engineers to review and monitor quality and process improvements
- Makes recommendations to management team regarding equipment requirements or improvements
- Apply sound Project Management skills in the areas of Resource, Time, Risk, Quality, Comminication, and Procurement Management
Experience
- Engineering Degree
- Must have box build/unit build/system integration experience
- Experience manufacturing medical devices
- Experience with FDA regulations and compliance
Job Type: Full-time
Pay: $80,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Tampa, FL: Reliably commute or planning to relocate before starting work (Required)
Experience:
- medical device box build/unit build/system integration: 1 year (Required)
Work Location: One location
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