Senior Mechanical Design Engineer
Location
Secunderabad | India
Job description
- Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of Medtronic Neurovascular team within MEIC
- As a member of MEIC NV 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 Life
- Be part of an extended 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.
- Coordinates and/or leads all aspects of product remediation activity related to EU-MDR. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.
- 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.
- Prepare and develop test plan, and manage verification and validation activities for products and processes in support of EU-MDR requirements.
- Prepare necessary component /assembly drawings and release of the same in the PLM systems.
- Support 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.
- Should maintain accountability and successfully deliver projects/tasks assigned.
- 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.
Must have / Minimum Qualification
- Bachelor s Degree in Mechanical Engineering or equivalent with 5 to 10 years of Product Development experience.
- In-depth experience in CAD tools such as Pro-E Creo/Solid works is expected.
- 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.
- Strong understanding of medical device standards , guidelines and regulations per ISO 13485, ISO 14971 and Design controls ( 21 CFR Part 820).
- 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.
- Able to effectively work with cross functional teams in a multinational matrix organization
- Superior written and verbal communication skills required.
- Good attitude and team player.
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