This position has the responsibility and authority to support image guided surgical systems through the product life cycle, with primary focus in Safety Risk Management and Post Market Monitoring analytics. This position has the opportunity to establish risk management infrastructure with the goal to improve efficiency and to facilitate data-driven decisions. This position may also help support post-market monitoring aspects of the Quality Engineering team to support trending and metrics, escalation of issues, resolution of exceptions, and hazard assessments as required. This position reports to the Engineering Supervisor and performs tasks with minimal supervision.
• Maintain the Risk Management process, including application of ISO 14971.
• Facilitate hazard assessments and product failure mode investigations in a cross-functional team.
• Help establish Risk Management Infrastructure by developing and maintaining report automation tools.
• Interface with SalesForce team to update/modify coding
• Lead activities to establish and maintain the Post-Market Monitoring requirements associated with Risk Management.
• Support post-market quality data analytics, utilizing data analytics tools where possible
• Provide statistics support to analyze data and identify product failure trends as needed.
• Track and monitor action items from monthly post-market monitoring meetings. Work with assigned owners to meet assigned due dates.
• Prioritize and manage multiple priorities effectively with minimal direction.
• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Follow all Medtronic Navigation Quality System procedures to ensure that all applicable quality standards and regulations are met such as FDA, ISO and European Medical Device Directive.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: Less than 10%
• B.S./B.A. in Engineering or technical related field
YEARS OF EXPERIENCE
• 2+ years of previous experience in a quality or support position in a regulated environment with B.S./B.A.
• 0+ years of previous experience in a quality or support position in a regulated environment with M.S./M.A. or Ph.D
SPECIALIZED KNOWLEDGE REQUIRED
• Working knowledge of ISO 14971
• 4+ years of previous experience in a quality position in the Medical Device industry
• Strong understanding of FDA regulations
• Working knowledge of scripting language (Python, Matlab etc).
• Knowledge of statistical techniques and reliability tools.
• Proficient with data analysis.
• Well-developed written communication skills.
• Experience working with cross-functional design/development teams.
• Previous experience in managing multiple projects having multiple tasks.
• Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, WEEE, RoHS, and IEC 60601 standards.
• Direct or indirect Project management experience.
• Formal training in Six Sigma methods (or equivalent) combined with project deployment experience at the green belt or black belt is highly desirable.
• Experience with SalesForce coding
• PMP certification is preferred.
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.
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.