At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.
About the Role
Responsibilities may include the following and other duties may be assigned.
Shift:
Shift C: Week 1 Saturday, Sunday, Thursday & Friday (6pm - 6am)
Week 2: Monday, Tuesday & Wednesday (6pm - 6am)
Shift D: Week 1: Monday, Tuesday & Wednesday (6pm - 6am)
Week 2: Saturday, Sunday, Thursday & Friday (6pm - 6am)
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 including the measurement systems .
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.
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.
May develop and conduct statistical analysis or recommend additions to document work.
Provide support and troubleshooting for PLC's, motion control, vision applications, robotic systems, and PC controlled equipment.
Provide technical expertise in manufacturing process activities.
Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
Support PLC Software and Vision system validations.
Day-to-day Automation support.
Technical Assessment and Implementation Support.
Development, Review and/or Approve Testing Documentation.
Key Responsibilities
Execute validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and modified equipment.
Support equipment qualification and process validation efforts in collaboration with engineering, operations, and quality.
Maintain validated state of equipment through periodic review and change control processes.
CAPA & NCRM Support
Participate in Corrective and Preventive Actions (CAPA) investigations related to equipment failures or compliance gaps.
Analyze Non-Conformance Material Reports (NCMR) to identify root causes and implement corrective actions.
Cross-Functional Collaboration
Work closely with automation, controls, and IT teams to ensure validation alignment with digital systems.
Partner with Quality and Regulatory Affairs to ensure validation deliverables meet audit and submission requirements.
Compliance & Continues Improvement
Ensure validation activities comply with internal procedures and external regulations.
Participate in audits and inspections, providing validation evidence and documentation.
Use data from validation and maintenance activities to support equipment reliability and process capability improvements.
Must Have: Minimum Requirements
Requires Engineering Bachelor's Degree
Requires minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
Nice to Have:
Education & Experience
2+ years of experience in equipment validation, process validation, or quality assurance in medical device, pharmaceutical, or biotech industries.
Hands-on experience with automation equipment validation, including PLCs, motion control, and vision systems.
Understanding of GAMP 5, 21 CFR Part 11, ISO 13485, and EU MDR requirements.
Technical Skills
Knowledge in developing validation documentation (URS, FAT/SAT, IQ/OQ/PQ, TMV, risk assessments).
Understanding of Computer System Validation (CSV) principles for integrated control and information systems.
Attributes
Detail-oriented, analytical, and proactive problem solver.
Strong communicator, able to translate technical requirements into clear documentation.
Comfortable working in a regulated, audit-ready environment.
Key Performance Indicators (KPIs)
On-time completion of validation deliverables (IQ/OQ/PQ).
Audit readiness and zero critical findings related to equipment validation.
Validation cycle time reduction and improved efficiency.
Sustained validated state of equipment across manufacturing lines.
Compliance rate of validation documentation and change control closure.
Timely closure and effectiveness of CAPAs and NCMRs related to equipment.
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
MiniMed offers a competitive salary and flexible benefits package
At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
This position is eligible for a short-term incentive called the Operations Incentive Plan (OIP).
MiniMed Benefits (http://myminimedbenefits.com) Overview
About MiniMed
MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we've been committed to redefining what's possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it's needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.
Learn more about our business, and our mission here (https://www.minimed.com/en-us/about-us/) .
It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for MiniMed 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 (http://www.minimed.com/en-us/la-county-legal-notice) a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed 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.
