Manufacturing Process Engineer

Position: Manufacturing Process Engineer

Reporting to: Quality Manager

Location: Pillaipakkam (Factory)

Summary:

Roles responsibilities:

1.Conduct detailed process evaluations and gap analyses to identify areas for improvement in existing manufacturing operations.

2.Design and implement process optimization strategies to improve efficiency, reduce cycle times, and enhance product quality.

3.Collaborate with Engineering, Production, and Quality teams to develop and maintain Standard Operating Procedures (SOPs) and Work Instructions.

4.Monitor key process performance indicators (KPIs) such as cycle time, yield, scrap rate, and Overall Equipment Effectiveness (OEE) to meet or exceed operational targets.

5.Establish and maintain process control measures, including Statistical Process Control (SPC) techniques, to reduce variability and ensure consistent product quality.

6.Provide technical troubleshooting support to resolve process-related issues and improve equipment performance.

7.Lead process validation activities, including protocol development, execution, and documentation in compliance with regulatory standards (ISO 13485, 21 CFR Part 820).

8. Participate in root cause analysis, corrective action, and preventive action (CAPA) initiatives for process deviations and product quality issues.

9.Deliver training and provide guidance to production teams on new processes, procedures, and equipment to ensure successful implementation.

10.Stay current with advancements in process engineering, lean manufacturing, and automation technologies to continuously improve production capabilities.

Required Skills and Qualifications:

i. Bachelors degree in Mechanical, Plastics, Metallurgical, Process Engineering.

ii.2-3 years of experience as a Process Engineer in a manufacturing environment, preferably in medical device or medical product manufacturing.

iii. Strong knowledge of process optimization, lean manufacturing, Six Sigma, and statistical analysis.

iv Proficiency in process modeling, data analysis, SPC, and process simulation software.

v. Excellent problem-solving and analytical skills with the ability to manage complex process challenges.

vi. Working knowledge of process safety, risk assessment, and regulatory compliance (ISO 13485, ISO 14971, FDA 21 CFR Part 820).

vii. Effective communication and interpersonal skills for cross-functional collaboration. Strong project management abilities with proven capability to manage multiple priorities and deliver within deadlines.

Preferred candidate profile

Bachelors degree in mechanical, plastics, Process engineering, knows the regulatory compliance