Mechanical Design Eng Ii

**Careers that Change Lives**

**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.

**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.

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)