Principal Process Engineer
Company: Medtronic GmbH
Posted on: November 22, 2021
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:--
VALUE STREAM SUPPORT
--- 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
--- 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
--- 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
--- 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.
--- 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
- 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
--- Prior knowledge and experience in AutoCAD/Solidworks in
drafting plant layouts, manufacturing fixtures, engineering
--- 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
--- Demonstrated leadership, coaching and interpersonal skills.
--- Black Belt Certified a plus.
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
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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