Manufacturing Engineer - Bioprocessing Operations

Job description

3430499
Additional Cities

Westborough
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare BioPharma
Function

Manufacturing
Country/Territory

United States
Additional States/Provinces

Massachusetts
Postal Code

01581-1019
Role Summary/Purpose

In this key manufacturing role, provide technical support for the manufacturing lines and associates, sustaining excellence on levels of quality, compliance and safety standards. Consistently improve process quality and productivity through the application of Lean Six Sigma tools, cross-functional efforts and projects. Interface with global counter-parts to achieve program goals and integrate global activities when necessary. Co-lead introduction of new processes for new product development.
Essential Responsibilities

• Anticipates troubleshooting needs and performs complex troubleshooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution.
• Coordinates cross-functional efforts to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design, resuming operations in a timely manner and in compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations
• Drive improved product quality by identifying manufacturing issues developing advanced manufacturing cost-effective solutions and overseeing successful implementation into production.
• Utilizes initiative and independent judgement and constructs, evaluates, and improves complex engineering models using conceptual description and ideas.
• Monitor and improve productivity using Lean Six Sigma or related tools, while ensuring all customer commitments are met in a timely, quality and cost-conscious manner
• Participate in early focus on manufacturability in NPI and/or Advanced Technology programs. Drive rigor in process capability assessment, process layout, tooling and equipment development and QMS Design Transfer execution
• Clearly understand existing processes to provide support for manufacturing process technology roadmap, represent Manufacturing Engineering on Complaint Handling Unit and Change Control Board meetings
• Support and execute AME initiatives with wide business impact and ensure to share best practices across the Global Supply Chain
• Ensure regulatory compliance through Qualification & Validation. Responsible for ensuring rigor in determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance
• Help execute continuous simplification of QMS methods and their applications by working with cross-functional team including Operations and Quality Assurance.
• Work with the facilities and maintenance team to implement change and ensure the required production capacity is in place before it is required by customer demand.
• Actively engage with Environment, Health and Safety initiatives and ensure all requirements and policies are observed during change implementation.

• Aware of and comply with the Company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements
Qualifications/Requirements

• Associate’s degree in Mechanical, Electrical, Manufacturing or Computer Systems Engineering or related technical fields and 3 years of experience in engineering, production or troubleshooting of PC/server-based systems.
• Demonstrated troubleshooting, analytical and planning skills
• Ability to work independently
• Demonstrated strong communication skills (written and verbal) to all levels of the organization
Desired Characteristics

• Bachelor’s Degree in Mechanical, Electrical, Manufacturing or Computer Systems Engineering or related technical fields and 3 years of experience in engineering, production or troubleshooting of PC/server-based systems
• Co-op or internship experience in Manufacturing Engineering
• 6-sigma DMAIC & DFSS certified
• Experiences in Process Intensive manufacturing
• Solid working knowledge of GEHC QMS procedures for GMP
• Experienced developing tools and templates
• Demonstrated program or project management skills
• Demonstrated experience owning production processes / growing capability in yield and quality
• Experience working with global teams
About Us

GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Westborough