Manufacturing Engineer II

Medtronic • Juncos, PR

1d

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 Manufacturing Engineer is responsible for designing, implementing, and improving manufacturing systems and processes to ensure efficient production of high-quality products. They focus on optimizing manufacturing operations, reducing costs, and ensuring safety and compliance with standards. 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. Shift: Shift C: Week 1 Saturday, Sunday, Thursday & Friday (6pm - 6am) Week 2: Monday, Tuesday & Wednesday (6pm - 6am) Shift D: Week 1: Monday, Tuesday & Wednesday (6pm - 6am) Week 2: Saturday, Sunday, Thursday & Friday (6pm - 6am)

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.
• Knowledge 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.
• 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

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques including the measurement systems .
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.
• 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.
• May develop and conduct statistical analysis or recommend additions to document work.
• Provide support and troubleshooting for PLC’s, motion control, vision applications, robotic systems, and PC controlled equipment.
• Provide technical expertise in manufacturing process activities.
• Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
• Support PLC Software and Vision system validations.
• Day-to-day Automation support.
• Technical Assessment and Implementation Support.
• Development, Review and/or Approve Testing Documentation.
• Execute validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and modified equipment.
• 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.
• Ensure validation activities comply with internal procedures and external regulations.
• Participate in audits and inspections, providing validation evidence and documentation.
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees