Process Engineer - Medtronic - Irvine

Job description

The Process Engineer is responsible for supporting existing product lines to ensure safety, compliance and product availability. In addition, provide engineering support to manufacturing for transition of new products and scale-up for production.

Responsibilities:

· Identify, justify and implement significant data driven projects to reduce manufacturing costs.
· Design, develop and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
· Apply fundamental engineering principles and lean manufacturing methods to create practical solutions and provide technical support across functions.
· Develop highly capable manufacturing processes for existing products.
· Develop new manufacturing processes and equipment technologies to enable low cost, high quality manufacturing.
· Perform root cause analysis and develop corrective and preventative actions for quality systems and production issues.
· Maintain current production processes and assist in smooth transfer of new processes onto the production line.
· Create and maintain the documentation necessary to ensure the consistent manufacture of Medtronic products (Work Order, BOM, processes, drawings and shop floor paperwork)
· Troubleshoot equipment and procedures.
· Develop and execute process characterization, validation and material qualification plans

ABOUT MEDTRONIC: 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.

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.

EEO STATEMENT: 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: http:// www.uscis.gov/e-verify/ employees

DISCLAIMER: 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

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Desired profile

Basic Qualifications:

· Bachelor's degree in Biomedical Engineering, Material or Mechanical Engineering or similar field with 3+ years direct experience is required
· Experience developing innovative new processing technologies and tooling design and validation
· Understanding of design and process FMECA, process validation and variability reduction applications.
· Application of statistical and analytical methods such as SPC, SQC and DOE
· Process background (development, capability, optimization, validation) with a regulated industry.