Equipment Validation Engineer

Medtronic • Juncos, PR

2d

About The Position

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. A Day in the Life This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. The Equipment Validation Engineer is responsible for executing validation activities related to manufacturing and automation equipment. This includes developing and performing validation protocols to ensure equipment, systems, and processes meet regulatory, quality, and performance requirements under FDA, ISO 13485, and GxP frameworks. The role requires technical expertise in equipment qualification and compliance, with hands-on involvement in IQ, OQ, and PQ activities for new and modified equipment. The engineer will also support CAPA investigations and NCMR resolution related to equipment performance and compliance, collaborating closely with automation, controls, and quality teams to maintain validated states and drive continuous improvement. Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

Requirements

• Requires Engineering Bachelor’s degree
• Requires minimum of 2 years of relevant experience, or Master’s degree with a minimum of 0 years relevant experience.

Nice To Haves

• 2+ years of experience in equipment validation, process validation, or quality assurance in medical device, pharmaceutical, or biotech industries.
• Hands-on experience with automation equipment validation, including PLCs, motion control, and vision systems.
• Understanding of GAMP 5, 21 CFR Part 11, ISO 13485, and EU MDR requirements.
• Proficiency in developing validation documentation (URS, FAT/SAT, IQ/OQ/PQ, TMV, risk assessments).
• Understanding of Computer System Validation (CSV) principles for integrated control and information systems.
• Familiarity with data integrity, change control, and deviation management systems.
• Knowledge of validation tools and software (ValGenesis, Kneat, or equivalent) is an advantage.
• Detail-oriented, analytical, and proactive problem solver.
• Strong communicator, able to translate technical requirements into clear documentation.
• Comfortable working in a regulated, audit-ready environment.
• On-time completion of validation deliverables (IQ/OQ/PQ).
• Audit readiness and zero critical findings related to equipment validation.
• Validation cycle time reduction and improved efficiency.
• Sustained validated state of equipment across manufacturing lines.
• Compliance rate of validation documentation and change control closure.
• Timely closure and effectiveness of CAPAs and NCMRs related to equipment.

Responsibilities

• Develop and maintain validation documentation for manufacturing and automation assets in alignment with the Equipment Validation Master Plan (EVMP).
• Execute validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and modified equipment.
• Prepare and review protocols, reports, and risk assessments for automated systems, vision inspection systems, robotics, and digital factory technologies.
• Ensure validation packages comply with FDA 21 CFR Part 11, ISO 13485, EU MDR, and GAMP 5 principles.
• Support equipment qualification and process validation efforts in collaboration with engineering, operations, and quality.
• Maintain validated state of equipment through periodic review and change control processes.
• Participate in Corrective and Preventive Actions (CAPA) investigations related to equipment failures or compliance gaps.
• Analyze Non-Conformance Material Reports (NCMR) to identify root causes and implement corrective actions.
• Work closely with automation, controls, and IT teams to ensure validation alignment with digital systems.
• Partner with Quality and Regulatory Affairs to ensure validation deliverables meet audit and submission requirements.
• Interface with equipment suppliers and integrators during FAT, SAT, and commissioning to ensure validation expectations are met.
• Apply consistent validation documentation standards across projects.
• Ensure validation activities comply with internal procedures and external regulations.
• Participate in audits and inspections, providing validation evidence and documentation.
• Identify opportunities to improve validation processes and reduce cycle times while maintaining compliance.
• Use data from validation and maintenance activities to support equipment reliability and process capability improvements.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees