Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Downstream Manufacturing Operator II , will be responsible for maintaining a clean and orderly work environment. Completes work in a timely manner and performs all tasks with emphasis on safety. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with group lead and supervisor to resolve quality, production, and efficiency problems. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Performs the essential duties and responsibilities as listed in section below.
SHIFT SCHEDULE
Monday-Friday, 6:00AM-2:30PM. Potentially with opportunity to move to a two-shift operation after September 2025.
LOCATION NOTIFICATION:
Role is for a brand-new manufacturing facility that was opened in Braintree, MA to replace the Boston, MA facility. Initial training may be conducted out of the Boston, MA facility.
SUPERVISION RECEIVED
Reports to Assembly Supervisor
SUPERVISION EXERCISED
This position has no direct supervisory responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Primary responsibilities are to:
Work in a laboratory clean room environment.
Cut, inspect, package and label medical device products
Accurately and completely fill out required process documentation
Prepare shipments for sub-contract operations
Review process documentation for accuracy and completeness
Adherence to production schedule
Assemble and pack biologically derived medical devices in a clean room environment
Maintain compliance to cGMP/ cGDP / ISO 13485 (current Good Manufacturing Practice regulations / current Good Documentation Practice regulations / ISO 13485 regulations).
Must be comfortable working in a cleanroom with required PPE
Must be able to work in teams and assist site with additional tasks as requested
Must be able to have good vision and ability to read measurement instrumentation for inspection
Operate assembly, packaging, and inspection equipment
Maintain inventories of materials
Some lifting is required
Participate in process improvement activities
Perform all tasks with the emphasis on safety - Be respective of a ZERO tolerance policy
Perform all tasks safely and thoroughly in a timely manner
Follow SOP's, Work Instructions, and other company policies and instructions at all times
Use company provided PPE, manufacturing equipment, chemicals, and other equipment safely, responsibly, and for the purpose intended
Maintain good attendance and scheduled work hours
Other duties as required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
DESIRED MINIMUM QUALIFICATIONS
Minimum required education and experience: High School Diploma or equivalent with 2-4 years of experience Excellent Attendance Record
Ability to read, write and understand English
Computer literacy is required
Ability to work overtime as required
Reliable Transportation
TOOLS AND EQUIPMENT USED
This role routinely uses standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, fax machines, as well as other general office equipment). Computer skills including demonstrated proficiency with computer office application software.
All other equipment used is as follows:
Spatula VWR 82027-518 or equivalent
Digital Thickness Gauge
PP sheet
NIST Traceable Calibrated Ruler (metric and English units)
Product storage bag or equivalent
Isopropyl alcohol or equivalent
Clean room wipes or equivalent
Validated Heat Sealer
Validated Pneumatic Die Cutting Press
Cutting Dies as required for the pneumatic press
1/8' Extraction Tool
Validated Meshing Machine
Freezer (-10 to -40 deg. C)
Calibrated Timers
MasterFlex L/S Pump System (Tag# 01-0478 or equivalent)
Tubing - L/S-16 (900-001)
Check Valve (900-002 or equivalent)
PTFE tubing weights (900-003)
Validated Tray Sealer
PP Specimen Container (900-004 or equivalent)
Sterile, 50cc centrifuge tube (S-0040)
PP Handing Trays (900-005)
Tubing Cutter (900-006 or equivalent)
Soak Rack Cabinet
Appropriate Plastic Handling Carton/Pads
Hand Rolling Tool
Scissors (industrial shears), Grainger 5LC54 or equivalent
Validated perforating machine
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Ability to travel via car, train and/or airplane to domestic and international locations as needed.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\veterans\employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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