Quality Engineer II
Mounds View, MN - USA
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
A Day in the Life
In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS) you will play a vital part in ensuring product quality safety and reliability through postmarket activities. You will perform complaint investigations partner closely with engineering teams to identify and escalate risk file signals and support datadriven decisions that protect patients and clinicians.
This role supports the development and continuous improvement of procedures processes tools and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product support test method validation efforts and apply appropriate statistical methodologies to assess product performance and trends.
In addition this position contributes to building organizational capability by providing training to technicians and strengthening consistent compliant execution of quality practicesdirectly supporting patient safety and the CAS product lifecycle.
Job Description
In general the following responsibilities apply for the Quality Engineer II role. This includes but is not limited to the following:
Perform complaint investigations for Cardiac Ablation Solutions products
Collaborate with the engineering team to escalate risk file signals as appropriate.
Provide support with the development of procedures processes tools and techniques for performing product analysis.
Devise and implement methods and procedures for inspection and testing of returned product.
Support test method validation activities.
Apply and understand statistical methodologies as appropriate.
Provide training to technicians.
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
Bachelors degree in Engineering Science or a related technical discipline.
Minimum of 2 years of relevant experience in Engineering and or Quality or an advanced degree in Engineering Science or a related technical discipline with 1 years of relevant work experience in Engineering and or Quality.
Nice to Have
Medical device industry experience.
Familiarity with these regulations: FDA 21 CFR Part 820 EU 217/745 (EU MDR).
Familiarity with these standards: ISO 13485 ISO 14971 IEC 60601.
Knowledge of Microsoft Office Applications (Word Excel Access and PowerPoint) and Windows OS.
Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
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. For Office Roles: 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 and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
IC
About Company
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 excit ... View more