Manufacturing Engineer Medical Device

Overview

On Site
$50 - $70
Contract - W2
Contract - 12 Month(s)

Skills

Medical Devices
Mechanical Engineering
Manufacturing
PQ
OQ
Product Development
QMS
Machining
JMP
Biomedicine
Change Management
Collaboration
Design Of Experiments
Minitab
ISO 13485
IQ
Enterprise Resource Planning
Data Collection

Job Details

Hi,

Hope you are doing well.

We are currently sourcing for multiple Manufacturing Engineer roles with a strong focus on Medical Device manufacturing and validation protocols (IQ/OQ/PQ).

Role: Manufacturing Engineer
Location: Gainesville, FL & Sarasota, FL (Onsite)
Duration: Long Term Contract
Experience: 8+ Years (Medical Device Mandatory)

Required Skills:

  • IQ/OQ/PQ validation experience in medical parts manufacturing
  • 8 10 years of relevant process validation & manufacturing experience
  • Medical Device manufacturing background (Mandatory)
  • CNC Machining & DCM process knowledge
  • Strong knowledge of FDA, ISO 13485, and GMP
  • Proficient in QMS, ERP systems, statistical tools (Minitab, JMP)
  • Hands-on experience in protocol execution, documentation, process improvement
  • Experience with Design of Experiments (DoE) and statistical analysis
  • Effective cross-functional collaboration skills

Responsibilities Include:

  • Review & execute IQ/OQ/PQ protocols for compliance
  • Conduct process audits, update QMS documentation
  • Optimize manufacturing parameters via DoE for CNC/DCM
  • Perform sample measurements, data collection, and report generation
  • Lead change management and validation monitoring
  • Troubleshoot safety, quality, and delivery issues
  • Support new product development & process improvements

Qualification:

  • Bachelor s or Master s in Mechanical/Biomedical Engineering
  • Minimum 5+ years in medical device manufacturing with CNC/DCM exposure
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