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Principal Process Engineer

Company: Medtronic GmbH
Location: Irvine
Posted on: November 22, 2021

Job Description:

Careers that Change Lives--
Impact patient outcomes. Come for a job, stay for a career. Support, improve, and develop manufacturing methods, systems and processes to produce commercial medical devices, and associated products, that meet quality and cost requirements. Act as a primary technical contributor to cross functional teams to apply state of the art manufacturing process or systems technology to the production of commercial products, current product enhancements, or process improvements. Mentor and support fellow engineers to enhance overall team expertise. Act under general guidance of Engineering Manager on multiple assignments of complex nature and broad scope. We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Day in the life:--
--- Provides engineering support to improve, maintain or fix manufacturing processes on routine basis.
--- Routinely walks and checks the health of the value stream on a daily basis and addresses product related issues arising on the production floor.
--- Supports the organization in meeting production schedules through resolving technical, equipment or operational issues.
--- Equipment and Fixturing: Have a comprehensive understanding of the manufacturing operations and provides maintenance and troubleshooting solutions to all existing manufacturing equipment. Works closely with cross functional teams on the design of improvement efforts to all existing manufacturing equipment.
--- Defines and generates all required documentation in support of manufacturing products and processes. These includes designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures. Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary. Develops and implements solutions to complex problems and makes moderate to significant process improvements to enhance performance of job area. PROJECT SUPPORT
--- Develops, implements and provides comprehensive solutions to manufacturing methods/systems and process/ product improvements to optimize product performance.
--- Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Represents the organization as the primary contact for specific projects and initiatives. Communicates with internal and external groups at various levels of the organization.
--- Equipment and Fixturing: Have a comprehensive understanding of the manufacturing operations and provides equipment, fixturing, and process parameters solutions. Works closely with suppliers on the design of equipment and fixturing solutions.
--- Provides engineering support to drive non value stream related activities (i.e. CAPAs, improvement projects, product or process stabilization efforts, FTQs, etc.). Provides strategic solutions and implements plans to support process repeatability and stability through equipment qualification and process validation. Applies six sigma methodologies as appropriate.-- COST
--- Leads cost benefit analyses and implements process improvements solutions to reduce and/or optimize product costs. OTHER RESPONSIBILITES: SAFETY
--- Ensures a safe environment is maintained at all times.
--- Leads and supports initiatives to improve safety and compliance to applicable regulations.
--- Adherence to company's policies and procedures on maintenance of personnel hygiene and CEA cleanliness ensuring product safety QUALITY
--- Ensures activities performed are in compliance with quality system policies/regulations and Good Manufacturing Practices (GMP) at all times.
--- Reports any observed or reported process and/or product non-conformities to Quality and/or management.
--- Ensures compliance to training requirements at all times. PEOPLE LEADERSHIP
--- Provides guidance, training and coaching to team members within the job area.
--- Manages major/complex projects that involves delegation of tasks and review of others' work.
--- Act as team leader.-- TRAVEL REQUIREMENTS:
--- May be required to travel up to 5-10%. Must Have: Minimum Qualifications
- Bachelor's degree in Engineering or a related degree
- 7+ years of experience with Bachelors Degree OR 5+ years of experience with an Advanced Degree Nice to Have--
--- Demonstrated strong oral and written communications skills.
--- Prior knowledge and experience in project planning and monitoring.
--- Prior knowledge and experience in AutoCAD/Solidworks in drafting plant layouts, manufacturing fixtures, engineering drawings, etc.
--- Demonstrated solid interpersonal skills and ability to work in a team environment.
--- Green Belt Certified.
--- Experience in medical device manufacturing or manufacturing in highly regulated industry/environment.
--- Project management experience a plus.
--- Demonstrated communication skills in presenting information effectively and collaborating with different cross functional groups to achieve work objectives.
--- Demonstrated problem solving abilities and technical competency.
--- Demonstrated leadership, coaching and interpersonal skills.
--- Black Belt Certified a plus.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.--
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.--
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Irvine , Principal Process Engineer, Engineering , Irvine, California

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