Manufacturing Engineer

Stark Pharma Solutions Inc

Date: 1 week ago

City: Santa Rosa, CA

Contract type: Contractor

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Manufacturing Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Manufacturing Engineer

Location: Santa Rosa, CA or Irvine, CA (Onsite)

Duration: Long Term

Experience: 5+ Years

Job Overview

We are seeking an experienced

Manufacturing Engineer to support manufacturing operations, process optimization, and new product introduction within a regulated medical device environment. The ideal candidate will have expertise in manufacturing process development, validation, continuous improvement, and quality systems while collaborating with cross-functional teams to drive operational excellence.

Key Responsibilities

Develop, optimize, and support manufacturing processes to improve quality, efficiency, and productivity.
Troubleshoot production issues and implement corrective and preventive actions.
Lead process validation (IQ/OQ/PQ) and equipment qualification activities.
Support New Product Introduction (NPI) and transfer products into manufacturing.
Prepare and maintain manufacturing documentation, including SOPs, work instructions, and validation protocols.
Drive continuous improvement initiatives using Lean Manufacturing, Six Sigma, SPC, and Root Cause Analysis.
Support CAPA, NCR, Change Control, Risk Assessments (FMEA), and deviation investigations.
Collaborate with Quality, R&D, Production, Supply Chain, and Regulatory teams to resolve manufacturing challenges.
Ensure compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, GMP, and company quality standards.

Required Qualifications

Bachelor's degree in Mechanical, Manufacturing, Biomedical, Industrial Engineering, or a related field.
5+ years of Manufacturing Engineering experience in the Medical Device industry.
Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and GMP.
Experience with IQ/OQ/PQ, process validation, equipment qualification, and NPI.
Hands-on experience with CAPA, NCR, Change Control, FMEA, and Root Cause Analysis.
Knowledge of Lean Manufacturing, Six Sigma, SPC, and DFM principles.
Strong analytical, documentation, communication, and problem-solving skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,