Senior Controls Engineer
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Must Have: Minimum Requirements
BASIC MINIMUM QUALIFICATIONS
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
Bachelor's degree in an Engineering discipline with 4 years of experience, OR an advanced degree degree with 2 years of experience.
NICE TO HAVE:
- Strongly prefer degree in electrical engineering or control systems
- Strongly prefer FDA experience in either direct role in medical device/biopharma or consulting work on medical device/biopharma project
- Demonstrated proficiency in development of product requirements into machine User Requirement Specifications (URS) that mitigate patient risk through pFMEA traceable URS risk mitigations
- Knowledgeable in the understanding and development of software validation plan and reports
- Strong verbal and written communication and presentation skills
- Experience in applying Good Automated Manufacturing Practices (GAMP-5) to machine design
- Experience in legacy PLC platforms
- Experience in developing equipment for use in an ISO-5 clean room environment
- Understanding of Medical standards such as FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR. Understands medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation
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.
• 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, communicate with peers and co-workers, and sit for prolonged periods of time doing computer based work.
• Employee must occasionally lift and/or move up to 20 pounds.
• The noise level in the work environment is usually moderate.
• Typical office and lab working environments.
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.
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.
