Job Description

Careers that Change Lives

SUMMARY OF POSITION

Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development & sustaining efforts of Medical Devices products at MEIC.

As a member of the MEIC team, you will collaborate with the broader Medical Devices engineering team, clinical and commercial teams globally. You will enable design & development of medical devices/products and the associated infrastructure & capability building elements in close conjunction with the Global teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.
• Lead design reviews with cross functional team to ensure the design meets the product requirements for safety, reliability and manufacturability.
• Prepare necessary component /assembly drawings by following ASME guidelines and assist in 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 Requirements

PRINCIPAL WORKING RELATIONSHIPS

• The incumbent would work with the project management office at MEIC to ensure that resource forecasts, project metrics are correctly captured and presented to the leadership
• Frequent interaction with team members from other disciplines, cross functional teams, to understand project requirements and to adhere to project schedules.
• Possible interaction with clinicians, third-party vendors, manufacturers, and subcontractors.

EXPERIENCE

Bachelor\xe2\x80\x99s Degree in Mechanical Engineering or equivalent with 8 to 13 years of Product Development and Sustaining experience.

KNOWLEDGE, SKILL, AND ABILITY

• In-depth experience in CAD tools such as Pro-E Creo/Solid works is expected.
• Expertise in Robust Modeling and Detailing practices following the ASME guidelines.
• Strong Knowledge and application of GD&T including Tolerance stack-up analysis.
• Strong knowledge of metal manufacturing processes. Knowledge on 3D printing and additive manufacturing technologies is an add-on.
• Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred.
• 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.
• Strong knowledge of Engineering fundamentals and application of same during concept generation or re-design of products.
• 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.

Additional Information

• Posting Date: Jan 10, 2023
• Travel: No

Medtronic