Process Engineer II

Medtronic • Villalba, PR

8h

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 The role of a Process Engineer II is essential to ensuring the successful execution of high‑complexity product transfers, and maintaining compliance across regulated medical device processes. Within this scope, the Freezor Product Transfer, MJC to MVC Product Transfer, and the InterStim Trialing Kit and Accessories Product Transfer represent highly strategic programs that require an engineer with advanced technical capability, ownership, and cross‑functional influence. The Process Engineer II position is justified by the criticality, technical depth, and operational impact of these projects. 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 Bachelor degree in Engineering and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.

Nice To Haves

• Computer System Validation Proficient in executing Computer System Validation (CSV) processes, ensuring compliance with regulatory standards like FDA 21 CFR Part 11. Experienced in authoring validation documentation such as User Requirement Specifications (URS), Functional Specifications (FS), and Validation Protocols (IQ, OQ, PQ). Skilled in conducting risk assessments and system testing to ensure validated systems operate as intended. Adept at maintaining traceability matrices to link requirements, tests, and results during validation projects.
• FACTORYworks and SAP Configurations Experience Hands-on experience in configuring and optimizing FACTORYworks and SAP MES (Manufacturing Execution System) to streamline production workflows. Skilled in troubleshooting and resolving configuration issues to maintain system functionality. Experienced in integrating FACTORYworks with other enterprise systems, ensuring seamless data flow and operational efficiency.
• Special Builds Development of Instructions and Data Analysis Developed detailed work instructions for special builds, ensuring clarity and compliance with engineering specifications. Proficient in analyzing build data to identify trends, optimize processes, and improve product quality. Collaborated with cross-functional teams to create customized build instructions for unique product requirements. Experienced in leveraging data analysis tools to validate special build outcomes and ensure adherence to quality standards.
• Minitab Statistical Analysis Skilled in designing experiments (DOE) as part of Product Development Qualificaitons and analyzing results to optimize processes and improve product quality. Experienced in conducting capability analysis (Cp, Cpk) using Minitab to ensure processes meet specifications. Adept at visualizing data trends and insights through Minitab tools like Pareto charts and histograms.
• Process Validation Experienced in developing and executing comprehensive Process Validation protocols (IQ, OQ, PQ) to ensure manufacturing processes meet regulatory and quality standards. Proficient in performing risk assessments (e.g., FMEA) to identify and mitigate potential process failures during validation activities. Skilled in analyzing process data to evaluate consistency, repeatability, and reliability of validated processes. Adept at documenting Process Validation activities and creating detailed reports to ensure compliance with FDA, ISO, and other regulatory requirements. Experienced in collaborating with cross-functional teams to design and implement validation strategies for new and existing manufacturing processes. Proficient in using statistical tools (e.g., Minitab) to assess process capability (Cp, Cpk) and ensure processes operate within defined specifications. Skilled in revalidating processes after changes in equipment, materials, or methods to ensure continued compliance and quality. Knowledgeable in aligning Process Validation activities with industry guidelines such as FDA's Process Validation Guidance and ISO 13485.

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 A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. 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