Sr. Manufacturing Engineer

Medtronic; Humacao (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Medtronic is looking for a Sr. Manufacturing Engineer to lead process development, optimization, and continuous improvement for safe, efficient, high-quality production.

You will provide expertise in process design, equipment implementation, troubleshooting, and validation while partnering with Operations, Quality, Supply Chain, and R&D to drive manufacturing excellence. Responsibilities include designing production layouts, machine placement, and operation sequences, ensuring regulatory

Qualifications

• Requires a Bachelor's degree in Engineering and at least 4 years' relevant experience.
• Alternatively, a Master's with 2+ years or a PhD with 0 years.

Responsibilities

• Designs manufacturing processes and production layouts.
• Designs arrangement of machines within plant facilities for efficiency.
• Defines sequence of operations and procedures for fabrication of tools and equipment.
• Adapts machine or equipment design to factory and production conditions.
• Ensures compliance with regulations and quality standards.
• Supports process validation and DOE, IQ, OQ, PQ and Gage R&R.

Skills

Lean Manufacturing

Six Sigma

Technical writing

Regulatory knowledge

Problem solving

Education

Engineering bachelor degree

Master's degree

PhD

Tools

Minitab

JMP

Power BI

Python

Creo

AutoCAD

Gage R&R

DOE

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

The Sr. Manufacturing Engineer is responsible for leading and supporting manufacturing process development, optimization, and continuous improvement efforts to ensure safe, efficient, and high-quality production. This role provides technical expertise for process design, equipment implementation, troubleshooting, and validation while partnering cross-functionally with Operations, Quality, Supply Chain, and R&D to drive manufacturing excellence.

The Sr. Manufacturing Engineer serves as a subject matter expert and technical leader, helping to improve productivity, reduce cost, enhance product quality, and support new product introductions and manufacturing scale-up. The role also evaluates and implements process improvements, advanced technologies, and engineering solutions that strengthen operational performance and compliance.

Responsibilities may include the following and other duties may be assigned.

• 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.
• 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.

Required Knowledge and Experience

• 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.
• Engineering bachelor degree required

Nice to have

• Basic Knowledges in the following areas: Cutting tools
• CNC Programming
• Inspections gage
• GD&T basic knowledge
• Stack-up Analysis
• Process Validation DOE, IQ, OQ, PQ and Gage R&R
• Automation, Robotics, Integration, and PLC programming
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• Laser Welding & Etching, and Laser Annealing SME
• Shot Peening / Blasting Knowledge
• CAD Software Knowledge: Creo, AutoCAD, PartMaker
• Product Inspection Systems Design Optical product mix detection systems
• Assembly Processes Experience Assembly line design, process optimization, and troubleshooting
• CEA Knowledge Sterile packaging
• Sterilization: ETO, Gamma
• Sterile Cleaning
• Jigs and Fixture Design
• Anodizing Process
• Lean Manufacturing & Six Sigma (Green Belt or Black Belt certification)
• Advanced statistical analysis (DOE, SPC, MSA, process capability studies)
• Automation and digital manufacturing experience
• Equipment qualification & validation leadership (IQ/OQ/PQ)
• Risk management tools (FMEA, Fault Tree Analysis)
• Regulatory knowledge (FDA QSR, ISO 13485, GMP)
• Change management
• Data analytics tools (Minitab, JMP, Power BI, Python for data analysis)
• Cost reduction and value engineering
• Strong technical writing (protocols, reports, submissions support)
• Experience in Nonconformance investigations (NCMR, CAPA investigation)
• 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.

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.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the dut