24 days old

Senior Post Market R/D Engineer

Santa Rosa, CA 95404
Senior Post Market R/D Engineer


Santa Rosa, California, United States

Requisition #:


Post Date:

Nov 12, 2019

**Careers that Change Lives**

**Role Description**

The commercial product Sr. RD engineer will support post-commercial RD activities for the aortic endovascular business. This engineering position requires solid technical and leadership skills to maintain the rigor and diligence necessary for commercial product support. The engineer will apply technical principles, theories, and new concepts to collaboratively solve difficult technical problems and assess impact of proposed changes on form, fit and function of designs. The engineer will work under the limited direction of the post market lead but will have significant latitude in determining methods of solving problems, design and construction of analysis associated with commercial product testing.

**Position Responsibilities**

The post-market Sr. RD engineer is responsible for support and execution of the following in collaboration with the RD post market engineering team and lead. The commercial product engineer may be individually accountable for these actions.

Act as point person for technical questions from the field on commercial product.

Technical review and approval of change orders initiated by internal manufacturing sites

Review and approval of post market surveillance reports, and any subsequent updates for risk management documentation.

Root cause analysis related to commercial issues, including technical support of non-conforming material reports and product impact assessments.

Contributor or owner of corrective actions / preventative actions (CAPAs)

Support of rest of world (ROW) regulatory filings and regulatory recertification

Point of contact for technical questions from sales, marketing and clinical organizations for specification and design questions

Identify and correct product design deficiencies and ensure technical excellence and compliance of commercial products

**A Day in the Life**

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

+ Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.

+ Designs studies to investigate specific life science questions within field of expertise.

+ May be involved in product research and development and/or clinical trials.

+ Translates research discoveries into usable and marketable products.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

**Nice to Have Education**

Bachelors degree in engineering (Mechanical, Materials, Chemical, Electrical or Biomedical) with 4+ years of experience in medical device product development

Masters degree in engineering (Mechanical, Materials, Chemical, Electrical or Biomedical) with 2+ years experience in medical device product development

**Nice to Have Experience**

Experience with complex catheter based delivery systems

Experience with implantable cardiovascular devices

Experience in commercial manufacturing and production of medical devices

Prior experience in medical device quality systems is required and depth knowledge of the Medtronic Quality System is preferred

Experience in engaging with regulatory bodies, through regulatory filings and audit/inspection support. Comprehensive knowledge of ISO and FDA requirements and guidance.

Proficiency in SolidWorks

Knowledge of statistical analysis software and applications

Excellent communications skills (written and verbal)

Ability to work in a team

Self-starter and driver able to execute effectively and work efficiently

Proficient in mechanical engineering fundamentals and uses of good engineering judgement

**Travel Expectations: About 10% of the time**

**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.


Posted: 2019-11-14 Expires: 2019-12-21

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Senior Post Market R/D Engineer

Santa Rosa, CA 95404

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