Lead R/D Engineer Job Vacancy in Medtronic Nanakramguda, Hyderabad, Telangana – Updated today

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Company Name : Medtronic
Location : Nanakramguda, Hyderabad, Telangana
Position :

Job Description : Careers that Change Lives
Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of Medtronic Medical Surgical team within MEIC.
As a member of MEIC Medical Surgical (MS) you will collaborate closely with all the necessary stakeholders on the assigned tasks including your counterparts in the US to ensure timely and successful completion of the same.
A Day in the Life
Be part of an R&D team and provide engineering support for design, development or optimization of products, processes, tooling and/or equipment by collaborating with the necessary stakeholders.
Lead design reviews with cross functional team to ensure the design meets the product requirements for safety, reliability, and manufacturability.
EU-MDR submissions leads all R&D activities surrounding EU-MDR submission of Surgical Innovation products.
Prepare necessary component /assembly drawings by following ASME guidelines and assist in release of the same in the PLM systems like Windchill and Agile
Responsible on sustaining/release product engineering tasks and activities by ensuring compliance with applicable procedures.
Assist in the preparation of Product Risk Management documents (DFMEA, Memo, report) along with Quality Engineering team.
Assist in creation of necessary DHF documentation along with relevant project stakeholders to ensure timely completion and release per project schedules.
Prepare reports, presentations, and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, customers.
Must learn and ensure compliance with all GBU design control processes and procedures.
Incorporate required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the design history file.
Should maintain accountability and successfully deliver projects/tasks assigned.
Assist fellow team members by coaching, mentoring and reviewing team deliverables whenever necessary to ensure timely completion of project milestones.
Ability to lead the project independently through milestones / stage gate exits towards successful closure with minimal or no supervision.
Must Have / Minimum Qualification
Bachelor’s Degree in Mechanical Engineering / Production or equivalent with 10 years of Product Development experience.
In-depth experience in CAD tools such as Pro-E Creo/SolidWorks and PLM software’s such as Windchill and Agile is expected
Experience in Product Remediation: Coordinates and/or leads all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals
Documentation: Prepares product development plans, leads and participates in design reviews, approves technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy.
Test Method Development: leads the development of clinically relevant test methods that adequately challenge product design and processes
Testing: Plan, develop, execute and manage verification and validation activities for products and processes in support of EU-MDR requirements.
Training: train engineers on design and process development and provide input to training of division procedures and policies.
Supervisory/mentoring/coaching: Mentor/coach R&D engineers through Product Development/Sustenance activities and procedures
Other Responsibilities may include, however are not limited to support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines
Strong familiarity with ISO 13485, 21 CFR 820, ISO 14971, EU MDD/MDR, EN ISO 60601-1.
Ability to create, assess or review applicable product DHF deliverables such as Risk files, Sterilization reports, Bio-compatibility reports etc. along with support from relevant project stakeholders.
Superior written and verbal communication skills required.
Good attitude and team player.

Preferred Qualifications:
Master’s degree in relevant engineering discipline (Mechanical, Biomedical, or other related engineering discipline).
Knowledge of cGMP and GLP is a plus.
Demonstrated hands-on technical aptitude regarding Class I, II, III Medical Devices.
Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
Ability to create and execute project plans.
Ability to lead cross functional teams.
Basic tooling, design and drafting knowledge.
Excellent oral and written communication skills.
Ability to analyze data, interpret results, and write reports. Proficient in statistic software.
Training in Six Sigma or Certified Design for Six Sigma.

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.
Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future.
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
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