Process Engineer II

Medtronic • Humacao, PR

5d

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 A Process Engineer is responsible for designing, implementing, and continuously improving manufacturing and operational processes to ensure efficiency, quality, safety, and cost effectiveness. The role involves analyzing process data, identifying root causes of issues, driving process optimization, and collaborating with cross‑functional teams to support product quality, regulatory compliance, and business objectives. 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 a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Engineering degree required
• 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.

Responsibilities

• 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.
• 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

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