Senior Design Assurance Engineer
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IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME:
REQUIRED EDUCATION:
• Bachelor’s Degree in Engineering, Bio-engineering or other technical discipline
REQUIRED YEARS OF EXPERIENCE:
• 4+ years (with Bachelor's) of similar work experience
• 3 years of experience in the medical device industry
SPECIALIZED KNOWLEDGE REQUIRED:
• Experience with medical device product and or process risk management
• Experience with developing new products or supporting commercial activities for class 3 medical devices
• Experience with medical device regulations and standards such as ISO 13485 and CFR 21 Part 820
• Proficient with statistics, statistical tools, and software
• Experience with process Development, Characterization, and Validation
• Experience with process improvement tools (i.e. Lean Manufacturing and Six Sigma)
• Experience utilizing Microsoft office (Word, Excel, PowerPoint, Visio)
• Experience with Solid Works
DESIRED/PREFERRED QUALIFICATIONS AND SPECIALIZED KNOWLEDGE:
• Master’s Degree in Engineering, Bioengineering, or Biotechnology
• ASQ Certified Quality Engineer or Six Sigma Black Belt a plus
• Internationally certified quality auditor designation a plus
• Experience and or knowledge in drug combination products
• Experience with combination drug/medical device products preferred
• Ability to solve very complex problems that require creativity
• Ability to deliver on multiple projects simultaneously
• Ability for reasoning and logical deduction
• Ability to shift between abstract and concrete concepts
• Excellent prioritization and verbal/written skills
• Strong collaboration skills
• Excellent prioritization and verbal/written skills
• Self-directed
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 for extended periods of time, and communicate with peers and co-workers.
• Required to sit or stand for extended periods of time
• Must be able to do light lifting, up to 25 lbs
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.
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
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.
