Manufacturing Process Engineer

Manufacturing Process Engineer

Job Description Summary

This role is responsible for establishing, validating, and improving manufacturing processes for medical device production while ensuring regulatory compliance, product quality, and operational efficiency. The position supports new process setup, new product introduction (NPI), and continuous improvement initiatives, working closely with production, quality, and engineering teams.

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.

Job Description

Roles and Responsibilities

• Support the setup of new processes through validation and qualification, risk assessment using PFMEA (Process Failure Mode and Effect Analysis), and training personnel through SOPs (Standard Operating Procedures).

• Lead Compliance and Environmental, Health & Safety initiatives aligned to plant goals and regulatory expectations.

• Improve product quality by identifying manufacturing issues, developing practical and cost-effective solutions, and ensuring smooth implementation into production.

• Collaborate with Production Associates to address manufacturing and quality challenges related to methods, processes, tooling, equipment, and product design.

• Contribute to new product introductions by supporting process layout, tool development, equipment selection, and ensuring regulatory compliance through Validation & Verification planning, execution, and analysis.

• Coordinate manufacturing changes and releases, ensuring accurate and timely implementation.

• Support Lean manufacturing initiatives to enhance operational efficiency and reduce waste.

• Ensure processes comply with all applicable regulations and maintain a safe work environment by taking corrective actions where safety concerns are identified.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering.

• 4+ years of experience in Manufacturing Process Engineering, preferably in Medical device manufacturing

• Experience in handling regulatory and process audits

• Preferred experience with FDA and regulatory requirements.

• Hands-on experience with design change processes and implementation.

• Experience using ERP systems such as Oracle or SAP.

• Experience with Six Sigma methodologies and CAPA processes.

• Ability to provide clear design and assembly feedback to engineering teams.

Desired Characteristics

• Methodical, organized, responsive, and strong analytical problem-solving skills.

• Solid understanding of materials, components, product design, and quality standards (e.g., ISO 13485).

• Working knowledge of company technologies, production capabilities, tools, and assembly processes; proficiency with CAD tools is an advantage.

• Ability to manage work within defined budgets and timelines, with strong awareness of health and safety requirements.

• Leadership experience or the ability to guide/coordinate technicians can be an asset where applicable.

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.

Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare.

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Additional Information

Relocation Assistance Provided: Yes

Experience Level

Mid Level