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 Manufacturing Engineer II and make a lasting impact in the medical device industry! In this role, you will be at the forefront of driving manufacturing excellence, transferring processes, and ensuring the production of innovative, life-saving technologies. Based in 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, FACTORY works configurations and special builds development, with a focus on continuous improvement and operational efficiency. What makes this opportunity even more exciting is the defined timeline-this role is structured to conclude on or before 2028, providing a clear and impactful opportunity to deliver results and leave a legacy.
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.
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.
this role is structured to concludeon or before 2028
Must Have: Minimum Requirements
Requires a Bachelor Degree in Engineering (BSME, BSEE)
and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
. Nice to Have-
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.
FACTORY works Configurations Experience
Hands-on experience in configuring and optimizing FACTORYworks MES (Manufacturing Execution System) to streamline production workflows.
Proficient in customizing FACTORYworks modules to align with unique manufacturing requirements.
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.
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).
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\name=signon&co\num=30601&co_affid=medtronic)
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 solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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 solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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