General Electric Principal Engineer – Single Use Consumables in Westborough, Massachusetts

Role Summary:

The Principal Engineer - Single Use Consumables provides technical leadership for the production team. You will develop solutions to launch new products in to manufacturing, performing Process Mapping, Manufacturing Risk Evaluations, Tool and Equipment selection, Process Developments and Qualification and initiating new processes and methods to improve safety, reduce product cost and/or improve product quality.

Essential Responsibilities:

  1. Ensure early focus on manufacturability in New Product Introduction and/or Advanced Technology programs

  2. Represent manufacturing on cross-functional business project teams and process development teams

  3. Drive rigor in process capability assessment, process layout, tooling and equipment development and QMS design Transfer execution

  4. Lead Design for Manufacturability (DFM) initiatives by preparing Process Flow Charts, Product Risk Maps, and pFMEA to identify opportunity to reduce cycle time, improve quality, and avoid EHS Issues. Driving LEAN manufacturing implementation

  5. Ensuring regulatory compliance through Validation & Verification; responsible for determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance

  6. Drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing successful implementation into production

  7. Design and develop new processes to support both short and long term business plans with productivity, capacity and quality improvements

  8. Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design

  9. Develop new process and workstation designs to reduce cycle time and support the lean manufacturing initiative

  10. Monitor and improve productivity, while ensuring all customer commitments are met in a timely, quality and cost-conscious manner

  11. Troubleshoot production and packaging equipment

  12. Specify and expedite planned maintenance routines on all production equipment and systems

  13. Co-ordination of manufacturing releases

  14. Lead Compliance, as well as Environmental, Health & Safety efforts in support of plant goals

  15. 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

Qualifications/Requirements:

  1. B.S. Degree in Mechanical, Electrical, Industrial Engineering or related technical degree and 10 years’ experience years of experience in production, engineering or troubleshooting of manufacturing equipment used for Medical Device Manufacturing

  2. Previous experience with ISO 13485 and single use consumables used in Healthcare or Bio-Pharma Industry

  3. Previous experience in Bag manufacturing Process Development including selection and qualification of equipment

  4. Previous experience in automated production equipment and ability to trouble shoot

  5. Experience with manufacturing processes and quality control on: Film Handling, Port Sealing, Packaging of Bags and Manifolds Experience with GD&T and Statistical Process Control in Manufacturing Environment

  6. Demonstrated problem-solving abilities using analytical and logical thinking skills

  7. Demonstrated understanding of QA-QC and testing procedures

  8. Demonstrated analytical and planning skills

Desired Characteristics:

  1. Demonstrated capability to excel in a Cross-Functional Team Environment

  2. Demonstrated ability to identify & implement best practices

  3. Demonstrated ability to perform with high levels of ambiguity and complexity

  4. Experience with industrial automation and ergonomic design

  5. Previous Project Leadership Experience

About Us:

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.

Learn More About GE Healthcare – Life at http://www.gelifesciences.com/

Sciences at http://www.gelifesciences.com/

Learn More About Careers at GE Healthcare – Life at http://goo.gl/AEAOb0

Sciences at http://goo.gl/AEAOb0

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . 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.

Locations: United States; Massachusetts; Westborough

GE will only employ those who are legally authorized to work in the United States for this opening.