Senior Mechanical Design Engineer- JT

Medtronic•Tempe, AZ

3d•$106,400 - $159,600•Hybrid

About The Position

At Medtronic, you’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this critical and exciting role as a Senior Mechanical Design Engineer, you will be responsible for the tooling and fixturing that ensures our cutting edge process technologies create quality products for our patients. You will support implantable cardiac and neuromodulation medical device manufacturing value streams at Medtronic's Tempe Campus. You will support multiple organization spanning from early technology development, research and development, equipment and process development, and operations. The Senior Mechanical Design Engineer will contribute to the development of new products that meet application, business, and customer requirements. Collaborate with design colleagues to ensure equipment and tooling designs are capable of meeting performance targets. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the organization.

Requirements

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

GD&T certification
DRM or DFSS Green Belt or Black Belt certification
Experience in the medical industry, or experience in an FDA regulated industry

Responsibilities

Research, plan, design, verify, validate and develop mechanical and/or electromechanical devices and systems to support new technology and business development. This may include instruments, controls, robots, resonance systems, hydraulic systems, or heat transfer systems to support various manufacturing operations. This would be done while working with metals, plastics, and ceramics through various fabrication processes.
Recommend various technology options or approaches for systems, processes, facility, or program improvements in terms of safety, performance, efficiency, ergonomics, and/or cost.
Perform design, implementation (ordering, payments negotiations, and installations), and integration activities to support daily-use tooling (ex. shipping trays, device handling, and transfer tooling) in 24/7 manufacturing operations.
Design mechanical, electromechanical and mechatronic systems, subsystems, and tooling solutions to support complex medical device manufacturing operations. Preferred outcomes will be innovative, lean, and cost effective.
Responsibilities will include assessing component and assembly manufacturability needs, developing solutions, and ensuring successful integration into the manufacturing environment by participating in Design for Reliability and Manufacturability (“DRM”) and Six Sigma design processes.
Interact with, and direct, suppliers and vendors to manage results and outcomes through this extensible workforce/resource.
Perform risk / failure mode assessment, plan and conduct performance and safety testing and ensure mitigations are in place for designs.
Write engineering reports and create presentations of analytical and interpretive nature as required to document and communicate results.
Institute design changes based on internal and/or external customer feedback.
Collaborate on the development of appropriate testing to verify the product meets internal and/or external customer requirements.
Prepare documentation in accordance with relevant internal Standard Operating Procedures and Design Control.
May be responsible for the transfer from R&D to manufacturing.
Responsible for technical execution of experiments utilizing six sigma methodologies.
Lead, direct, and/or review the work of technical team to execute the technical plan.
Define QMS approach such as leveragability of designs/documentation.
Create and evaluate prototype concepts to generate model and lead down selection process for final concept and model approval.
Assess the performance of developed devices through execution of structured experimental plans to drive data-based decisions.
Define and develop tests and test methods to meet product requirements.
Partake in verification and validation of designs and processes.
Provide technical mentoring to less experienced engineers and technicians.
Develop strong partnerships and work effectively with cross-functional team members.
Perform job functions in accordance with applicable GMP and ISO standards.
Comply with applicable FDA and international regulatory laws and standards.
Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
May be involved in product research and development and/or clinical trials.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)