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Manufacturing Engineer - Extrusion Molding Polymer Processing - Senior

Santa Rosa, CA 95404
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Manufacturing Engineer - Extrusion Molding Polymer Processing - Senior


Santa Rosa, California, United States

Requisition #:


Post Date:

Apr 25, 2019

The **_Senior Manufacturing Engineer_** in
Santa Rosa Extrusionis
responsible for evaluating, improving, and controlling the overall performance
of extrusion manufacturing areas. This role leads and interacts closely with
the Operations team as well as RD PDP Process Development, Quality,
Reliability Engineering, Microbiology, Maintenance/Facilities, and Regulatory
Affairs. This position provides technical extrusion leadership to other engineering
resources, including finished device products, supporting extrusion manufacturing.
This position provides supervision, guidance, coaching, and training to other
engineers and will provide technical extrusion support to all Extrusion Manufacturing
Operations areas.

Santa Rosa Extrusion seeks candidates who will meet our customers expectations
by striving without reserve for the greatest possible reliability and quality
in our products, processes, and systems by being accountable, having a voice,
and taking action.

**A Day in the Life:**

+ Establishes technical direction andguidance to support operational plans for Santa Rosa Extrusion that will havea long-range impact on results.

+ Resolves problems that span a widerange of difficult and unique issues across extrusion activities.

+ Interacts with extrusion internaland external customers and vendors at various levels, including executiveleadership, on significant issues.

+ Manage large, complex initiativesof strategic importance to the organization involving largecross-functional teams.

+ Accountable for identifying andimplementing GMP (Good Manufacturing Practices) that apply to specificproduction areas.

+ Provide training as needed toensure production team understands and follow GMP and processinstructions.

+ Leads/owns CAPA (Corrective and PreventativeActions) to resolve production and customer issues.

+ Leads failure analysis and issueresolution activities to ensure corrective and preventative action isaccomplished.

+ Identify process improvement opportunitiesand provide technical solutions via analysis and hands-on interaction withdesignated processes, including troubleshooting of manufacturing issueswhen they occur.

+ Utilize project management skillsto drive continuous improvement initiatives to optimize yield, quality,cycle time and/or ergonomics.

+ Lead efforts to investigate anddevelop new technology related to extrusion products.

Responsibilities may include the following and other duties may be assigned.

+ Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

+ Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.

+ Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

+ Adapts machine or equipment design to factory and production conditions.

+ May incorporate inspection and test requirements into the production plan.

+ Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

+ Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.

+ Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

+ Ensures processes and procedures are in compliance with regulations.


Bachelor of Science in Engineering and 4-7 years relevant experience or an advanced degree with a minimum of 2-4 years of experience.

Understanding and wide application of technical principles, theories, and concepts of manufacturing processes in a medical device regulated environment

Technical knowledge of manufacturing processes and process validation (IQ/OQ/PQ)

Knowledge of medical device and pharmaceutical regulations

Experience handling multiple tasks concurrently

Extensive knowledge of quality systems

Nice to Have:

MS degree in Plastics Engineering

Proven success in project management

Inventory Systems Management

Team dynamics skills (communication, accountability, decision making, feedback, meeting management, managing conflict)

Technical background in plastics machinery and/or processing

5+ years of extrusion process/project engineering experience

Documented success rate of new product launch contributions and/or completed capital projects managed on time and on budget

Experience in medical device products manufacturing.

Supervisory experience

Experience with line layout, line balancing, and capacity modeling / analysis

Knowledge in Lean Manufacturing / DMAIC / Six Sigma methodologies

Experience in medical product manufacturing / assembly operations

Aptitude for quickly learning and simulating a broad array of information

Excellent data analysis skills, and proficient in the use of statistical tools in problem solving

Preference to know and understand end to end value stream concepts

Experience and/or knowledge in DOE, SPC, FMEA, GMP, QSR, QMS

**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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.


Posted: 2019-04-30 Expires: 2019-10-06
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Manufacturing Engineer - Extrusion Molding Polymer Processing - Senior

Santa Rosa, CA 95404

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