Engineers (All Levels)

Medtronic•Humacao, PR

1d•Onsite

About The Position

A Manufacturing Engineer focused on NPI supports the introduction of new products and processes into manufacturing by partnering closely with R&D, Quality, Supply Chain, and Operations to ensure designs are manufacturable, scalable, and compliant. Day to day, they translate product designs into robust manufacturing processes by developing process flows, work instructions, PFMEAs, and equipment requirements, while leading or supporting process and equipment validations. They manage manufacturing readiness for design changes, pilot builds, and production ramp‑up, troubleshoot issues during early builds, and drive continuous improvements to stabilize yield, quality, and cost as new products transition to full production. A Process Engineer supports daily production by ensuring manufacturing processes run efficiently, safely, and in compliance with quality and regulatory requirements. They spend time on the production floor troubleshooting process and equipment issues, addressing nonconformances, and working closely with operators, Quality, and Maintenance to resolve problems quickly. In parallel, they analyze manufacturing data, drive continuous improvement initiatives, maintain process documentation, and support equipment, process validations, and change implementation to improve efficiency, quality, and cost.

Requirements

Level I - Requires a Baccalaureate degree and 0 years relevant experience. Engineering degree required
Level II - Requires a Baccalaureate degree and 2 years relevant experience or Master's degree with a minimum of 0 years relevant experience. Engineering degree required
Senior - Requires a Baccalaureate degree and 4 years relevant experience or Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience. Engineering degree required
Prin Level- Requires a Baccalaureate degree and 7 years relevant experience or Master's degree with a minimum of 5 years relevant experience or PhD with 3 years relevant experience. Engineering degree required
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.

Nice To Haves

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 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)

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.
Ensures processes and procedures are in compliance with regulations.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.