At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Within our Design Quality team for Released Product Engineering, for the ACM [Acute Care & Monitoring] OU, we continually focus on Patient Safety, Compliance and Customer Needs. We provide global quality engineering support in the design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products.
Ensuring rigor in the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you.
Come for a job, stay for a career!
A Day in The Life Of:
As our Design Quality engineer, key responsibilities will include:
* Critically review new and modified product designs to determine their impact to existing or new product requirements and their effect on patient safety, standards compliance, and reliability
* Review and implement changes to internal corporate methods and procedures
* Ensure that planned projects and changes to existing products are conducted in compliance with Medtronic’s QMS, ISO13485, EU-MDR and the FDA Quality System Regulations
* Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dFMEA, and risk management report)
* Assist in the creation of verification and validation test plans, protocols and reports
* Review testing and analysis for standards and product requirements compliance
Key Skills & Experience
* Level 8 bachelor’s degree Engineering, Quality Management or related disciplines and minimum 2+ years of experience in a regulated industry
* Experience in ISO 13485, Risk Management ISO 14971 and EU-MDR regulations
* Knowledge of verification/validation test plan development
* Proficiency with CAPA and root cause failure analysis
* Comparative Statistical techniques, sampling plans, GR&GR, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis
* Familiar with statistical software tools (Minitab, Stat Graphics, Statistical)
* Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS
* Familiar with DMAIC or DMADV(DFSS) methodologies
* DFSS / Lean Green Belt preferred
Medtronic offer a competitive salary and flexible Benefits Package
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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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.
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 95,000+ 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.
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.
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