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Senior Reliability Engineer - Mounds View, MN

MED Medtronic Inc
Full-time
On-site
USA-MN Mounds View Central United States of America

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

Senior Reliability Engineer

Careers That Change Lives

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

In this exciting role as a Senior Quality Engineer supporting the Cardiac Ablation Solutions organization, you will have responsibility for supporting the inspection and test plan used by the lab technicians executing product analysis of returned product. The Engineer will be capable of working on complaint investigations with limited supervision. He or she will exhibit an ability to interact with co-workers in a way that facilitates sharing of information and timely resolution to complaint investigations. The Engineer shall be capable of interfacing with various manufacturing sites and facilitate the transfer of information in a timely manner.

The Cardiac Ablations Solutions Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

This position is in Mounds View, MN within the Cardiac Ablation Solutions Operating Unit and requires 3 days onsite per week.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Senior Reliability Engineer role. This includes, but is not limited to the following:

  • Lead reliability activities to resolve product related issues (manufacturing, field complaints, etc.)
  • Apply critical thinking to determine the need for further actions or to document audit defendable rationales when no further actions are required.
  • Lead design verification activities including test method development, sample size rationale, and product acquisitions to support all products (as needed).
  • Lead test method validation activities using appropriate statistical methodologies.
  • Own and update Risk Management files (Risk Management Report, Product Hazard Analysis, DFMEA, etc.) including risk assessments for projects and issue understanding.

Must Have - Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

  • Bachelor’s degree in Engineering, Science, or a related technical discipline.
  • Minimum of 4 years of relevant experience in Engineering and or Quality, or an advanced degree in Engineering, Science, or a related technical discipline with 2+ 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.

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Des carrières qui changent la vie

Chez Medtronic, nous repoussons les limites de ce que la technologie peut faire pour que demain soit meilleur qu'hier, ce qui en fait un lieu de travail passionnant et gratifiant. Nous apprécions ce qui vous rend unique. Faites partie d'une entreprise qui pense différemment pour résoudre les problèmes, faire des progrès et apporter des innovations significatives.

Dans ce rôle passionnant d'ingénieur qualité senior au sein de l'organisation Cardiac Ablation Solutions, vous aurez la responsabilité de soutenir le plan d'inspection et de test utilisé par les techniciens de laboratoire qui effectuent l'analyse des produits retournés. L'ingénieur sera capable de travailler sur des enquêtes de réclamation avec une supervision limitée. Il ou elle fera preuve d'une capacité à interagir avec ses collègues de manière à faciliter le partage d'informations et la résolution rapide des enquêtes sur les plaintes. L'ingénieur doit être capable d'assurer l'interface avec différents sites de production et de faciliter le transfert d'informations en temps utile.

L'unité des solutions d'ablations cardiaques développe des thérapies de restauration de la vie et des solutions de soins de santé qui couvrent le continuum des soins, en intégrant des technologies et en appliquant des preuves cliniques et économiques pour accroître l'accès des patients, améliorer l'efficacité des procédures et obtenir des résultats positifs pour les patients.

Ce poste est situé à Mounds View, MN, au sein de l'unité opérationnelle des solutions d'ablation cardiaque et nécessite 3 jours de présence sur place par semaine.

Nous sommes convaincus que lorsque des personnes de cultures, de sexes et de points de vue différents se réunissent, l'innovation en est le résultat - et tout le monde y gagne. Medtronic agit en ce sens, en créant une culture inclusive où vous pouvez vous épanouir.

De manière générale, les responsabilités suivantes s'appliquent au poste d'ingénieur fiabilité senior. Cela inclut, mais n'est pas limité à ce qui suit :

  • Diriger les activités de fiabilité pour résoudre les problèmes liés aux produits (fabrication, plaintes sur le terrain, etc.).
  • Faire preuve d'esprit critique pour déterminer la nécessité d'actions supplémentaires ou pour documenter des justifications défendables lorsqu'aucune action supplémentaire n'est nécessaire.
  • Diriger les activités de vérification de la conception, y compris l'élaboration de méthodes d'essai, la justification de la taille de l'échantillon et l'acquisition de produits pour soutenir tous les produits (selon les besoins).
  • Diriger les activités de validation des méthodes d'essai en utilisant les méthodologies statistiques appropriées.
  • Il possède et met à jour les dossiers de gestion des risques (rapport de gestion des risques, analyse des risques produits, DFMEA, etc.), y compris les évaluations des risques pour les projets et la compréhension des problèmes.

Conditions requises - Exigences minimales

POUR ÊTRE PRIS EN CONSIDÉRATION POUR CE POSTE, VEUILLEZ VOUS ASSURER QUE LES EXIGENCES MINIMALES SONT ÉVIDENTES DANS VOTRE CURRICULUM VITAE

  • Diplôme d'ingénieur, de scientifique ou d'une discipline technique connexe.
  • Un minimum de 4 ans d'expérience pertinente en ingénierie ou en qualité, ou un diplôme supérieur en ingénierie, en sciences ou dans une discipline technique connexe avec 2 ans ou plus d'expérience pertinente en ingénierie ou en qualité.

Expérience souhaitée

  • Expérience dans l'industrie des dispositifs médicaux.
  • Familiarité avec les réglementations suivantes FDA 21 CFR Part 820, EU 217/745 (EU MDR).
  • Familiarité avec les normes suivantes : ISO 13485, ISO 14971, IEC 60601.
  • Connaissance des applications Microsoft Office (Word, Excel, Access et PowerPoint) et du système d'exploitation Windows.
  • Solides compétences en matière de communication écrite et orale et capacité à travailler en coopération au sein d'une équipe interfonctionnelle.

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.

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.

Salary ranges for U.S (excl. PR) locations (USD):$101,600.00 - $152,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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 90,000+ 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.

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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.