Manufacturing Engineer – Medical Devices
Location: Petaluma, CA
Type: Contract-to-Hire
Pay Rate: $55–$60/hr (W2)
On-site Requirement: 100% on-site, Monday–Friday

Overview
Kelly Engineering is seeking a skilled Manufacturing Engineer for our client, a rapidly growing medical device manufacturer. This position will focus on equipment validation, process improvement, and compliance in a GMP-regulated environment. The ideal candidate will have strong technical expertise, excellent communication skills, and the ability to work effectively in a fast-moving setting.

Responsibilities

• Plan and execute validation of manufacturing lines, equipment, and processes

  
  

• Drive process improvement initiatives to improve efficiency, yield, and product quality

  
  

• Collaborate with cross-functional teams including Quality, R&D, and Operations

  
  

• Ensure compliance with FDA, ISO 13485, and GMP standards

  
  

• Create and maintain SOPs, work instructions, and validation documentation

  
  

• Support audits and inspections with technical input and documentation

  
  

• Participate in investigations, CAPAs, and continuous improvement activities

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related discipline

  
  

• 5+ years in GMP-regulated medical device manufacturing or pharma industries

  
  

• Hands-on experience with manufacturing equipment, including pumps and piping systems

  
  

• Strong background in equipment and process validation

  
  

• Excellent written and verbal communication skills, with ability to write clear SOPs and technical documents

  
  

• Ability to work independently and handle multiple priorities in a fast-paced environment

Schedule:

• Monday–Friday, 8 AM–5 PM (some flexibility to meet project timelines)

Apply Now – If you meet these requirements and want to be part of a growing, innovative company, we want to hear from you.

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