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Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Group Leader, Machinist will be responsible for using equipment to package finished products according to established specifications and perform operations as described by Standard Operating Procedures (SOPs) under Good Manufacturing Practices (GMPs).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Operates diverse types of equipment used to manufacture various types of Medical Devices established within the manufacturing processes and quality requirements. 

Operations being performed depend on cell assignment and product being manufactured but may include and are not limited to, cutting raw material, drilling, milling, bending, deburring, buffing, laser etching, wax injection, dipping, dewax, pour, assembly or packaging/labeling.

Equipment used may be but not limited to assembly equipment, pack/labeling equipment, etc. Equipment used depends on product being manufactured or operation being performed. Operator will inspect finished and in-process product for dimensional and cosmetic attributes according to defined specifications. Operator will also assemble, package, and label various orthopedic medical devices following specific procedures, and operate various manual and semi-automatic packaging equipment.

All operators use various types of measuring instruments including numerous types of gauges, micrometers, calipers, comparators, pH meters, go/ no-go gages, conductivity meters, visual inspectional, and digital titrators for chemical analysis.

All operators use diverse types of hand tools but not limited to wrenches, screwdrivers, deburr knives etc.

Operator Asset Care on a regular basis such as, but not limited to, checking and replacing coolant, checking fluid oils, emptying metal chips, maintenance regarding equipment breakdowns, belt changing, and process chemical maintenance.

Completes rework, as necessary, on products rejected by process in the specification. Works with other production areas and cell leaders, as necessary, to resolve quality problems.

Works following appropriate safety practices to prevent accidents to self or co-workers.

Know and follow all policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Ensures that in process quality checks are completed following established quality specifications. Interface with quality and other production employees to resolve problems.

Works in accordance with all requirements for manufacturing medical devices (e.g. FDA QSR, ISO 9000, ISO 13485).

Completes required documentation as required by process, and inspection sheets, work instructions, and the document traceability.

Lifting, 5 to 25 pounds, is required on a regular basis and heavy lifting, over 50 pounds, is required on occasion.

Ability to learn and adhere to specific procedures according to the department training plan.

Sets the standard for production performance, effective communication, promoting positive morale and supporting employee involvement programs.

Works with the PP&L group to ensure completion of production schedule and resource allocation for unscheduled events, i.e. call-outs.  

Develops and regularly reports on department metrics, including OEE, production output, equipment downtime, continuous improvement activities, safety improvements, and other departmental tracking as defined by the Business Unit.

Monitors machine downtime and escalates repairs through Maximo.

Monitors and maintains operating supply inventories, as assigned by supervisor.

Knows and follows all laws and policies that apply to one's job, and maintains the highest levels of professionalism, ethics and compliance at all times.

Partners with engineering team to ensure completion of expansion & validation activities in a timely manner, acting as subject matter expert where applicable or providing correct point of contact to operator subject matter expert.

Supports department communications, including Daily Direction Setting and ad-hoc announcements, and actively participates in feedback sessions with questions and knowledge of department current state.

Maintaining training by keeping up with the training matrix.

Acts as a change agent, remaining open-minded in a continually changing environment.

Escalates machining and personnel issues interfering with seamless production to supervisor.

Additional duties as assigned.

QUALIFICATIONS:

High school diploma or equivalent

Five years hands-on experience in an applicable manufacturing.

Ability to read, comprehend and apply documentation such as safety, operating and maintenance instructions.

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.

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