Operator II - Circulatory Restoration
About The Position
Johnson & Johnson is hiring an Operator II – Circulatory Restoration for its team in New Brighton, Minnesota. The Operator assembles, tests, and inspects products according to documented Manufacturing Process Instructions (MPIs), including cleaning and setting up the workstation with the proper equipment and materials. The Operator records activities on Lot History Records (LHRs) and other Quality Records and follows documented requirements and company quality, safety, and environmental policies. The position includes building subassemblies and final assemblies, performing inspections, monitoring equipment and quality results, preparing and auditing product labels and packaging, and recording work to maintain product-lot traceability. The Operator supports inventory control, documents scrap and non-conformances, identifies causes of rejects, suggests process improvements, and supports Lean Manufacturing and In-Process Kanban practices. The role also involves training across and rotating between up to six operations, becoming a workstation subject matter expert and line trainer, and potentially contributing to pilot development builds. The role requires working in a Controlled Environment Room and following applicable procedures and documentation practices. The position may involve prolonged sitting and lifting objects up to 15 pounds. Overtime may be required to accommodate business needs.
Requirements
- High school diploma or equivalent experience.
- Ability to read and communicate in English.
- 1–3 years of experience in a manufacturing environment involving small parts.
- Ability to work in and follow Controlled Environment Room (CER) procedures.
- Ability to assemble and test medical devices, including gluing and assembly under a microscope, while following MPIs, SOPs, Work Instructions, and related procedures.
- Requires moderate supervision for routine work and close supervision for special assignments.
- Ability to complete detailed LHRs while following Good Documentation Practices (GDP).
- Ability to work in a fast-paced environment while following SWMI safety standards.
- Ability to work overtime to accommodate business needs and maintain reliable attendance.
- Ability to work in a team, build effective interpersonal relationships, communicate well, and clearly communicate with coworkers and peers.
- May need to sit continuously for prolonged periods and lift objects weighing up to 15 pounds.
Nice To Haves
- Medical device manufacturing experience is preferred.
- Preferred skills listed: Administrative Support, Agile Manufacturing, Assembly Operations, Detail-Oriented, Execution Focus, Factory Acceptance Test (FAT), Good Manufacturing Practices (GMP), Innovation, Learning Agility, Manufacturing Processes, Manufacturing Science and Technology (MSAT), Mechanical Equipments, Plant Operations, Process Oriented, Prototyping, Repair Management, Structural Fabrication, and Technologically Savvy.
Responsibilities
- Clean workstations and equipment and perform line clearance according to documented procedures.
- Build subassemblies and/or final assemblies according to MPIs.
- Perform in-process inspections of components, materials, subassemblies, and final assemblies to verify specifications and support data collection and analysis.
- Monitor equipment parameters and in-process inspection results, making adjustments according to documented procedures when needed to meet quality specifications.
- Prepare labeling, audit labeled product against LHR product information, assemble final packaging, and record and disposition labeling materials as required.
- Ensure correctly labeled products are released to finished goods according to documentation.
- Prepare packaging for shipment, apply inventory-control labeling, and verify boxed quantities against LHR records.
- Record work details and complete required LHR sections to ensure finished-lot traceability.
- Assist a supervisor and/or lead with inventory control issues, such as scrap transactions and back flushing finished products and subassemblies.
- Document scrap resulting from out-of-specification equipment, materials, or processes and notify a supervisor when disposition or corrective action may be needed.
- Suggest process improvements; identify rejects, explain root causes, and provide improvement solutions.
- Train to become a workstation subject matter expert and line trainer.
- Champion and support In-Process Kanban integrity and follow Lean Manufacturing practices on the production floor.
- Continuously train and master up to six operations and rotate assembly stations as needed to meet production goals.
- Potentially contribute to pilot development builds by following engineering guidelines and providing feedback on manufacturing methods.
Benefits
- Annual performance-based cash bonus, subject to the applicable plan and company discretion.
- Medical, dental, and vision coverage.
- Life insurance and short- and long-term disability coverage.
- Business accident insurance and group legal insurance.
- Company consolidated retirement plan (pension) and 401(k) savings plan, subject to eligibility.
- Vacation: up to 120 hours per calendar year.
- Sick time: up to 40 hours per calendar year; up to 56 hours for employees residing in Washington State.
- Holiday pay, including floating holidays: up to 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
