Sr. Process Engineer

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**Join our Mission-Driven team as a Sr.Process Engineer and make a lasting impact in the medical device industryIn this role, you will be at the forefront of driving manufacturing excellence, transferring processes, and ensuring the production of innovative, life-saving technologies.Based on Medtronic Villalba Campus, you will collaborate closely with cross-functional teams to deliver high-quality results aligned with our commitment to improving patient outcomes.This position offers a unique opportunity to contribute to meaningful projects, including computer system validation, process validation, data analysis, FACTORYworks configurations and special builds development, with a focus on continuous improvement and operational efficiency.If you are passionate about innovation, thrive in a fast-paced environment, and are eager to make a difference, we invite you to apply and be part of a team dedicated to transforming healthcare.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.**Must Have: Minimum Requirements:*** Requires a Bachelor Degree in Engineering* Requires minimum of 4 years of relevant experience or an advanced degree with a minimum of 2 year of relevant experience or PhD with 0 years relevant experience.**Nice to Have (Preferred**):**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 Qualifications 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 *****.**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 duties of this job, the employee is regularly required to be independently mobile.The employee is also required to interact with a computer, and communicate with peers and co-workers.Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.# **Benefits & Compensation****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).## ## # **About Medtronic**We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and#J-*****-Ljbffr