Medtronic Prin Extrusion Manufacturing Engineer in Santa Rosa, California
Prin Extrusion Manufacturing Engineer
Santa Rosa, California, United States
Oct 18, 2016
A key technical leader who will substantially advance the technical skills and competencies of the extrusion engineering organization. Provide Extrusion Engineering and Program Management Leadership in the concept, prototyping, clinical evaluation, process/equipment development, sustaining engineering, and production scale up of new products and components from RD, Supply Chain, manufacturing transfers and business acquisitions. Provide Extrusion Engineering and Program Management Leadership in the management of manufacturing operations sustaining engineering and product transfer from RD to Manufacturing. Provide Extrusion Engineering and Program Management Leadership in product transfers from RD to Manufacturing. Provide Extrusion Engineering and Program Management Leadership in product line transfers from outside facilities to internal manufacturing in California. Provide Extrusion Engineering and Program Management Leadership in product line transfers from current manufacturing to outsourced manufacturing vendors. Provide Extrusion Engineering and Program Management Leadership in scale up of component manufacturing for other businesses within Medtronic. Provide Extrusion Engineering and Program Management Leadership for development and scale up of low cost manufacturing for legacy product lines. Define equipment, process, material and operator specifications for manufacturing. Approach all engineering activities with the objective to reduce variability in operator, materials, machines and manufacturing processes to improve profitability at the Santa Rosa, CA site. Ensures Santa Rosa Extrusion Center of Excellence strategic business objectives are met. Ensures Quality, Service, Cost, and Technology expectations are realized for our customers.
•Insure compliance to Corporate, Divisional and Site Process Validation procedures and policies.
•Insure compliance to Corporate, Divisional and Site Equipment Design/Development and Control procedures and policies.
•Provide a project leadership and management role in defining and completing operations based projects that target established Annual Operating Plan goals and objectives.
•Develop Manufacturing Processes that will reduce operating costs, reduce labor, reduce product variability, increase yields and improve the potential of product line transfers to outsource vendors.
•Make manufacturing processes:
oScalable in terms of volume and applicability to future designs
oConsistent to reduce variability and potential for error
oTransferable (well-documented, de-skilled, less training needed)
•Lead Process and Equipment Development efforts with an end goal of successfully completing IQ/OQ/PQ activities (validation) in support of achieving commercialization objectives and timelines.
•Forecast the impact of potential changes. Be aware of cultural, historical, and systemic obstacles that will limit the ability to effectively implement change, and work to overcome them.
•Provide a project leadership and management role with outside organizations in the transfer of manufacturing from the Massachusetts facilities to outsourced manufacturing vendors.
•Generate and manage project documentation according to prescribed policies and guidelines.
•Conduct Team meetings and Design Reviews in conjunction with assigned projects and in accordance with prescribed policies and guidelines.
•Evaluate proposed designs and processes for manufacturability with associated recommendations for improvements.
•Manage engineers and technicians in accomplishing project goals.
•Develop product and process specifications, generate E-Specs, QC Specs, material specs, incoming specs in support of new product introduction.
•Provide detailed project plans and updates as required. Manage projects to meet agreed upon timelines.
•Using influence management skills interface with engineering, materials control, planning, finance, document services, marketing and manufacturing in setting and achieving common project goals.
•Prioritize and balance workload of multiple project assignments based on business and functional objectives.
•Bachelor’s degree in engineering discipline
YEARS OF EXPERIENCE
•9+ years with BS
•7+ years with MS
SPECIALIZED KNOWLEDGE REQUIRED
•Ability to lead a team.
•Ability to work on a Team
•DOE, SPC, FMEA, GMP, ISO, 6 Sigma
•AutoCAD or Solid Works Proficiency
•Knowledge of Statistical Software and Practices
•Knowledge of Materials and Related Processes
•Technical Writing Skills
•Verbal, Written and Presentation Skills
•Interpersonal and Project Management Skills
•MS in engineering discipline
•Medical device experience
PHYSICAL JOB REQUIREMENTS
•The physical demands described here 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. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, lift, and reach with hands and arms. Specific vision abilities required by this job include normal vision.
•Some travel required as needed
•Some international travel required as needed
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
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.
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The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.