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Sr Design Assurance Engineer

Medtronic


Location:
Albion, MI 49224
Date:
03-09-2020
2020-09-032021-02-08
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Job Details

Sr Design Assurance Engineer

Location:

Rice Creek, Minnesota, United States

Requisition #:

20000DO5

Post Date:

Aug 31, 2020


**Careers that Change Lives**


In this exciting role as a Sr Design
Assurance Engineer you will have responsibility for influencing product quality
and reliability outcomes across new product development as well as ensuring
project compliance to the Quality Management System.The Sr Design
Assurance Engineer is a member from the Quality function assigned to a
cross-functional product development team for the Targeted Drug Delivery (TDD)
business within the Restorative Therapies Group (RTG).


The **Restorative Therapies Group** 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.


**Neuromodulation** delivers innovative therapies and solutions for neurological diseases, pain,
and spasticity


Responsibilities may include the following and
other duties may be assigned.


+ Integralmember of design team required to participate in activities related to thequality and reliability of the design.

+ Workclosely with Development Engineering to assure appropriate requirementdefinitions are established.

+ Participate in design verification and designvalidation for new products and modifications to existing products.

+ Assistin the development and implementation of methods and procedures forinspecting, testing, and evaluating products and production equipment.

+ Bea key contributor in problem solving efforts to identify and resolvechallenging quality issues to ensure production of safe and effectivemedical devices.

+ Serve as a Design Assurance reviewer/approver ondesign control documents, specifically those associated with product testingand characterization

+ Completereviews and audits of Design History File (DHF) documentation.

+ Drivefunctional excellence, lessons-learned, and business and qualitymanagement system improvement

+ Coachand support project team members on compliance with Quality Systemrequirements


**Must Have: MinimumRequirements**


+ Bachelors Degreein Engineering, Science or technical field with 4+ years of work experience inEngineering and/or Quality OR Advanced degree in Engineering, Science ortechnical field with 2+ years of work experience in Engineering and/or Quality


**Nice to Have**


+ 2+ years relevant engineering experience with implantable medicalproducts

+ Mastersdegree in engineering, science or business

+ Workingknowledge of multiple quality disciplines, especially reliability, safetyand compliance

+ Qualityor reliability engineering experience in product development

+ Workingknowledge of FDA regulations and ISO standards applicable to implantablemedical devices and to drug-device combinations including FDA 21 CFR Part820, Part 211, ISO 13485

+ Strongworking knowledge of quality systems and quality assurance processes andprinciples, with a focus on development and or verification/validationactivities

+ ASQCertification in Quality or Reliability.

+ Strongoral/ written communication skills and interpersonal skills.

+ Ability to exercise judgment within broadly defined practices andpolicies in selecting methods, techniques and evaluation criterion forobtaining solutions.

+ Self-Starter and accountable, with sharp focus on quality and customerexperience.

+ Technical writing skills


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets 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. 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. (ADA-United States of America)
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.
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