Manufacturing Engineer

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

Job Title: Manufacturing Engineer

Location: Piscataway, NJ

Experience: 0 3 Years

Job Summary

We are looking for a motivated Manufacturing Engineer to join our medical device manufacturing team in Piscataway, NJ. This role is ideal for recent graduates or professionals with up to 3 years of experience who are eager to build a career in medical device manufacturing. The Manufacturing Engineer will support production processes, improve manufacturing efficiency, and ensure products meet quality and regulatory standards.

Key Responsibilities

• Support day-to-day manufacturing operations to ensure efficient production.
• Assist in developing and improving manufacturing processes and work instructions.
• Participate in process validation activities, including IQ, OQ, and PQ.
• Investigate manufacturing issues and implement corrective and preventive actions (CAPA).
• Collaborate with Quality, Production, R&D, and Supply Chain teams to resolve production challenges.
• Assist in root cause analysis using problem-solving tools such as 5 Whys and Fishbone.
• Support equipment qualification, maintenance coordination, and process optimization.
• Ensure compliance with FDA regulations, GMP, ISO 13485, and company quality standards.
• Prepare and maintain manufacturing documentation, SOPs, batch records, and engineering change documentation.
• Monitor production metrics and recommend continuous improvement initiatives to enhance quality and productivity.
• Participate in Lean Manufacturing and Six Sigma improvement projects.
• Support new product introductions and manufacturing transfers.
  
  

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or a related field.
• 0 3 years of manufacturing engineering experience, preferably in the medical device or regulated manufacturing industry.
• Basic understanding of manufacturing processes and engineering principles.
• Knowledge of GMP, FDA regulations, and ISO 13485 is preferred.
• Familiarity with process validation (IQ/OQ/PQ) is a plus.
• Strong analytical and problem-solving skills.
• Good communication and teamwork abilities.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
  
  

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,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com