Equipment Development Engineer II - CDM de 24 mois

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

About Medtronic

At Medtronic, we push the limits of medical technology to transform healthcare for millions of patients worldwide. We are committed to innovation, quality, and collaboration. Join us and be part of a purpose-driven team improving lives every day.

Position Overview

We are seeking a Equipment Development Engineer to lead the design, automation integration, acquisition, and qualification of production equipment for medical devices. This role combines technical expertise with project management responsibilities to deliver robust, compliant, and cost-effective equipment solutions. The Equipment Engineer drives cross-functional collaboration, supplier management, and continuous improvement initiatives to ensure equipment reliability and alignment with Medtronic’s Maintenance Excellence (MEX) strategy.

Key Responsibilities

Design & Development

• Lead the design and development of specialized manufacturing equipment for medical device fabrication.

• Define and validate User Requirement Specifications (URS) and ensure alignment with business and manufacturing needs.

• Establish equipment architecture standards, including hardware, safety, ergonomics, and automation.

• Collaborate with third-party manufacturers and integrators to oversee the design, customization, and build of equipment.

• Ensure early integration of MEX principles (Early Equipment Management – EEM) during design phases.

Project & Supplier Management

• Lead the full lifecycle of equipment acquisition projects, from concept and business case development to commissioning and handover.

• Manage project scope, budget, timelines, and risks to ensure on-time and on-budget delivery.

• Coordinate with suppliers, contractors, and automation integrators, ensuring compliance with Medtronic quality standards.

• Drive cross-functional collaboration with Manufacturing, Quality, Regulatory, and Validation teams.

• Prepare and deliver project updates to stakeholders and leadership.

Validation & Testing

• Plan, lead, and approve Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

• Oversee the execution of qualification protocols (IQ, OQ, PQ) for new equipment.

• Provide technical leadership during debugging, commissioning, and process validation phases.

• Ensure equipment meets regulatory, performance, and safety requirements.

Automation & Process Improvement

• Define and integrate automation strategies, including PLC programming, robotics, motion control, vision systems, and HMIs.

• Conduct risk analyses (e.g., eFMEA) to ensure robust equipment performance and safety.

• Drive process optimization initiatives to improve cycle times, reduce costs, and enhance product quality.

• Stay current on emerging automation technologies and implement innovative solutions where applicable.

Maintenance Excellence (MEX)

• Embed MEX methodology into equipment development and acquisition projects.

• Lead EEM activities to ensure equipment is designed for reliability, maintainability, and performance.

• Support the development of preventive and predictive maintenance strategies.

• Drive standardization of best practices across sites and functions.

Documentation & Compliance

• Ensure complete and accurate documentation for all equipment lifecycle stages, including design specifications, validation protocols, and training materials.

• Guarantee compliance with applicable regulatory requirements, including FDA, ISO 13485, and GMP.

• Provide technical expertise during internal and external audits.

Travel Requirements

• Be flexible to travel up to 20% of the time to suppliers, other Medtronic sites, and on-site validation and commissioning activities.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Electrical, Automation, or related engineering field.

• 5+ years of experience in equipment development, automation, or manufacturing engineering.

• Proven project management experience, including supplier and budget management.

• Strong knowledge of equipment qualification processes (URS, DR, FAT, SAT, IQ, OQ, PQ).

• Expertise in automation systems: PLCs, HMIs, robotics, sensors, vision, and industrial communication protocols.

• Familiarity with risk management tools (e.g., FMEA, eFMEA).

• Strong problem-solving, analytical, and communication skills.

• Knowledge of GMP, ISO, FDA regulatory standards.

• PMP certification or equivalent project management training is a plus.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here