Equipment and Vision Systems Development Engineer

We are seeking an 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 Engineer drives cross-functional collaboration, supplier management, and continuous improvement initiatives to ensure equipment reliability and alignment with Medtronic’s Maintenance Excellence strategy.

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

Responsibilities may include the following and other duties may be assigned

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.

Required Knowledge and Experience

• Bachelor’s or Master’s degree in Mechanical, Electrical, Automation, or related engineering field.
• 3+ 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.