CRE - Assembly Operator III

Johnson & Johnson Innovative Medicine•Raynham, MA

1d•Onsite

About The Position

At Johnson & Johnson, health is everything. The company leverages healthcare innovation in Innovative Medicine and MedTech to prevent, treat, and cure complex diseases, delivering smarter, less invasive, and personalized treatments. Johnson & Johnson is committed to an inclusive work environment that respects diversity and dignity. The MedTech sector focuses on developing next-generation treatments at the intersection of biology and technology. Johnson & Johnson plans to separate its Orthopaedics business into a standalone company, DePuy Synthes, within 18 to 24 months. If hired, the employee would transition to DePuy Synthes. The CRE - Assembly Operator III operates various machinery in an assigned cell to produce medical devices, including implants. The equipment used varies by product and operation. Under the direction of a supervisor or cell lead, the operator ensures production requirements are met, product quality is maintained, machine maintenance schedules are followed, and safety rules are adhered to.

Requirements

Vocational, Certificate, Technical, or Associate’s degree required, or equivalent combination of education and experience.
Generally requires 6–8 years of relevant work experience in a manufacturing or regulated environment.
Ability to learn, understand, and consistently follow detailed procedures in accordance with the department training plan.
Ability to read, comprehend, and apply documentation including safety requirements, operating instructions, and maintenance procedures.
Ability to communicate effectively, both verbally and in writing, with diverse internal and external stakeholders.
Ability to work collaboratively and professionally with coworkers and the public.
Ability to perform job duties in accordance with established policies and procedures and in compliance with applicable civil rights requirements.
Demonstrated understanding of health, safety, and environmental requirements.
Ability to deliver clear oral and written communications and effectively utilize electronic systems and digital tools.
Ability to travel at least 10%.

Nice To Haves

Lean and/or Six Sigma knowledge preferred.
At least six (6) months of hands-on experience working in a manufacturing environment preferred.
Demonstrated awareness of adjacent engineering disciplines and upstream stakeholders, including Quality Engineering and New Product Introduction (NPI) teams.
Demonstrated advanced knowledge of equipment effectiveness and manufacturing and maintenance excellence concepts, including Overall Equipment Effectiveness (OEE), Standard Operating Limits (SOL), or similar methodologies.
Demonstrated organized and analytical approach to problem-solving.
Knowledge of measuring instrumentation and/or measurement techniques.

Responsibilities

Operate a variety of equipment used to manufacture different types of medical devices in accordance with established manufacturing processes and quality requirements.
Complete assigned tasks using technology systems, including but not limited to PLM, MES, Microsoft Office, and ERP systems.
Perform regular Operator Asset Care activities, including but not limited to routine process machine maintenance.
Complete rework or reprocessing activities, as required, on products rejected during processing per specifications.
Collaborate with other production areas and cell leaders to resolve quality issues.
Perform all work in accordance with applicable safety practices and/or JSAs to prevent injury to self and others.
Know and follow all laws, policies, and procedures applicable to the role, maintaining the highest levels of professionalism, ethics, and compliance at all times.
Ensure all in-process quality inspections and checks are completed in alignment with established quality specifications.
Interact with Quality and other production personnel to resolve issues.
Work in compliance with all regulatory and quality system requirements for medical device manufacturing (e.g., FDA QSR, ISO 9000, ISO 13485).
Complete all required documentation, including process documentation, inspection sheets, work instructions, and document traceability records.
Lift up to 25 pounds on a regular basis, as required.
Demonstrate the ability to learn and adhere to detailed procedures in accordance with the department training plan.
Partner with the Engineering team to support expansion and validation activities in a timely manner, acting as a subject matter expert when applicable or identifying the appropriate operator SME.
Follow all applicable EHS&S policies and procedures, including PPE usage, standard work practices, and control measures.
Promptly report EHS&S incidents and Good Saves, complete all required EHS&S training and CAPAs on time, and ensure departmental waste is properly segregated (recycle vs. trash).
Communicate business-related issues or opportunities to the next level of management.
Follow all Company guidelines related to Health, Safety, and Environmental practices.
Ensure both personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
Perform other duties as assigned.
Perform cleaning and labeling activities depending on cell assignment and product.
Utilize a range of measuring instruments, including but not limited to pH meters, go/no-go gauges, conductivity meters, visual inspection tools, and digital titrators for chemical analysis.
Use various hand tools, including but not limited to spanner wrenches, screwdrivers, and similar tools.
Perform preventive maintenance on equipment as instructed.
Perform assembly, packaging, and labeling operations depending on cell assignment and product.
Operate manual or automated equipment, which may include but is not limited to Atlas Vac, Multivac, Ceratek, pin presses, air streams, assembly equipment, and packaging/labeling systems.
Use various measuring instruments, including pH meters, go/no-go gauges, conductivity meters, and visual inspection tools.
Perform order breakdown, visual inspection, documentation reconciliation, PO receipt, shipping, bag-and-tag, and shrink-wrap operations depending on cell assignment and product.
Operate manual or automated equipment, including but not limited to printers, shrink-wrap machines, palletizing machines, pallet jacks, and measurement equipment.
Perform product receipt, material handling, and storage activities, including but not limited to cycle counting and inventory management.
Operate Branson cleaning tanks, drying ovens, and various packaging equipment to complete assigned job duties.

Benefits

Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year