Manufacturing Process Engineer

GE HealthCare; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

GE HealthCare is seeking a quality and process engineer to set up and manage process quality and change management for medical devices at our Bengaluru facility.

You will validate processes, lead PFMEA risk assessments, and train personnel through SOPs to ensure compliant manufacturing; drive LEAN initiatives and coordinate change controls across production teams.

Qualifications

• Bachelor or Master’s degree in Electrical / Electronics / Electronics and Communication / Medical Electronics / Bio Medical Engineering.
• Sound knowledge of Manufacturing process.
• Knowledge of Electromechanical parts, assemblies.
• Hands on experience on Problem Solving, failure analysis tools (Lean & Six Sigma).
• Knowledge of Quality Management System (QMS).
• Good communication skills (Oral/Written).
• Strong bias for documentation & technical reports.
• Effective multitasking and ability to deliver on time and with quality.
• Ability to work in a team with good Interpersonal skills.

Responsibilities

• Set up new processes through validation and qualification, and assess risk via PFMEA; train personnel through SOPs.
• Lead Compliance, and Environmental, Health & Safety efforts in support of plant goals.
• Improve product quality by identifying manufacturing issues, developing cost-effective solutions, and implementing them in production.
• Collaborate with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design.
• Participate in new product introductions through process layout, tool development, and new equipment; ensure regulatory compliance through Validation & Verification.
• Coordinate manufacturing releases and change implementation.
• Drive LEAN manufacturing implementation.
• Provide safe processes compliant with local and federal regulations; address safety concerns with corrective actions.

Skills

Manufacturing process

Quality management

Problem solving

Documentation

Communication skills

LEAN & Six Sigma

Education

Bachelor/Master in Electrical/Electronics/Med Electronics

Tools

CAD tools

QMS software

Job description

Job Description Summary: Responsible for setting up and managing the process and quality of Products and also responsible for change management process of product and process.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Roles and Responsibilities

• Experience in setting up new process through validation and qualification, risk assessment through PFMEA (Process Failure Mode Effect Analysis), training of Personnel through SOP (Standard Operating Procedures)
• Lead Compliance, as well as Environmental, Health & Safety efforts in support of plant goals.
• Drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing successful implementation into production.
• Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design.
• Participate in new product introductions through process layout, tool development, and new equipment. Ensuring regulatory compliance through Validation & Verification - Plan execution and analysis.
• Co-ordination of manufacturing releases - Change implementation.
• Driving LEAN manufacturing implementation.
• Provide safe processes that comply with all local and federal regulations. Assure that corrective action is taken to resolve observed safety concerns in all areas.

Basic Qualifications

• Bachelor or Master’s degree in Electrical / Electronics/Electronics and Communication /Medical Electronics/Bio Medical Engineering.
• Sound knowledge of Manufacturing process
• Knowledge of Electromechanical parts, assemblies.
• Hands on experience on Problem Solving, failure analysis tools. (Lean & Six Sigma tools)
• Knowledge of Quality Management System (QMS).
• Good communication skills (Oral/Written)
• Strong bias for documentation & technical reports
• Effective multitasking and ability to deliver on time and with quality
• Ability to work in a team with good Interpersonal skills

Desired Qualifications

• Experience in Healthcare industry with ISO 13485 certification is preferable
• Experience in Six Sigma and CAPA process
• Should have skills like methodical, responsive, and highly organized; have good analytical skills..
• Excellent knowledge of materials, parts, product design and quality standards (ISO 13485) and requirements.
• Good knowledge of the company’s technology, production capabilities, tools and assembly methods and be able to use CAD (Computer aided design) tools.
• Good at working within budget and meeting deadlines; and have an excellent understanding of health and safety issues and requirements.
• Leadership skills can be an asset if their work entails overseeing and coordination of technicians

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.