Jobs Listing

Below, please find the list of positions Jarvik Heart, Inc. is currently accepting applications for.
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Assembly, Manufacturing, Production, Quality Department
Title Electronics Assembler
Categories Assembly, Manufacturing, Production
Start Date 2016-11-01
Location NYC
Job Information
Position:   Technician I
Department:   Manufacturing
Main Duties & Responsibilities, General: Support manufacturing at Jarvik Heart, Inc. through the assembly & inspection of product and completing proper documentation.
Duties & Responsibilities to include, but not limited to: –    Comply with Good Manufacturing Practices (GMPs), regulations, standards, and instructions at all times

–    Assemble/Disassemble/Test/Inspect/Troubleshoot/Clean sub-components and products at various stages of manufacturing

–    Weld/solder components using provided equipment and materials

–    Inspect products using calipers, micrometers, optical comparators, multi-meters, oscilloscopes and other measurement devices as applicable

–    Complete necessary documentation accurately and legibly

–    Assemble wire harnesses and/or cables, including measuring, braiding, cutting, crimping, soldering, and gluing

–    Use conformal coating, paint, silicone, isopropanol, and epoxy

–    Use and maintain equipment such as: injection molding machine; cleaning systems; polishing machines, test fixtures, and other equipment as deemed necessary

Quality Responsibilities, General: –    Support and comply with company Quality Policy and Quality Objectives, as well as other procedures, regulations, and standards

–    Control and/or quarantine non-conforming materials

–    Help develop and/or implement corrective/preventative actions

–    Maintain control & traceability over products and work in-process

Other Duties & Responsibilities: In addition to and/or inclusive of primary job function requirements, employee may be required to learn and/or assist with other duties and responsibilities.  Such duties may include, but are not limited to:

–    Participate in internal and external audits

–    Work with, and for, other team members: Follow instructions and provide feedback in a professional and constructive manner

–    Perform, or assist with, maintenance and calibration requirements

–    Proactively maintain cleanliness of work area, cleanroom, and controlled areas without direction

–    Debur and/or polish materials such as metals and/or plastics

–    Work with others on production status including schedules, deadlines, part-process status, inventory control, and other production issues

–    Must be able to wear protective equipment as directed up to 10 hrs/day, such as: Nitrile/vinyl gloves; surgical-style mask; isolation suit (Tyvek™ or similar) w/o makeup; hair net; shoe covers, as necessary

–    Must be able to lift and carry 30 pounds unassisted

–    Assist as necessary other areas and teams within Jarvik Heart, Inc

Reports to: Area supervisor

 

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Title Associate Production Planner
Categories Manufacturing, Production
Location New York, NY
Job Information
Position Summary: Support production related activities by assisting where necessary with planning & execution of manufacturing and assembly of medical devices.  Work closely with employees, supervisors, and managers to accomplish required actions and results for production needs.
Primary

Responsibilities

to include, but not limited to:

–    Comply with GMPs, regulations, standards, and other instructions at all times

–    Assist in scheduling and monitoring production, as well as vendor and supplier activities using various software tools and methods such as Intuitive ERP, MS Excel, and others

–    Work with, and for, other team members:  Follow instructions and provide feedback in a professional and constructive manner

–    Learn forecasting, planning, and coordinating the use of resources

–    Assist in monitoring purchase orders; professionally represent JHI while coordinating and working with suppliers & vendors

–    Identify methods to increase production rates and reduce production costs

–    Timely processing of work orders, assigned tasks, and shipments

–    Complete documentation accurately and legibly

–    Generate, update & maintain controlled documents related to production process

Quality

Responsibilities,

General:

–    Support and comply with company Quality Policy and Quality Objectives, as well as other procedures, regulations, and standards

–    Control and/or quarantine non-conforming materials

–    Participate in developing and/or implementing corrective & preventative actions

–    Maintain control & traceability over products and work in-process

Other Duties & Responsibilities: In addition to primary requirements, employee may need to assist with other duties and responsibilities, including, but not limited to:

–    Work with others on production statuses including schedules, deadlines, personnel, inventory control, and other production issues

–    Perform, monitor, or assist with, production, maintenance, and/or calibration requirements

–    Proactively maintain clean work areas and controlled areas without direction

–    Participate in internal and external audits, as well as physical inventory of product

–    Assist as necessary other areas and teams within Jarvik Heart, Inc, and/or as instructed

–    Must be able to lift and carry 30 pounds unassisted

Reports to: Manufacturing Manager

 

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Title Polishing Technician
Categories Manufacturing, Production
Salary based on experience
Location New York, NY
Job Information

Position Summary:  Hand finishing technician needed to perform hand finishing/polishing of precision metal components.  This includes, but is not limited to: manually removing machining marks from metal components, utilizing the operator’s skills and knowledge to efficiently perform the manual blending, polishing and creation of edge-breaks on precision components with focus on quality and attention to detail.  No specific experience is necessary, but candidates with polishing or other forms of metal finishing experience are preferred. Candidates from other industries such as jewelry manufacturing or dental technicians will also be considered.

 

Duties and Responsibilities: 

  • Expertly perform sanding, polishing, sizing, and deburring functions using hand and power equipment such as bench and hand grinders, polishers, and belt sanders.  May clean metal parts through the use of hand-wiping, solvent washing, and alkaline/caustic chemical cleaning.  Check required dimensions using calipers, micrometers, height gauges and other inspection devices.  Demonstrate proper and safe operation of equipment, and perform simple maintenance of same equipment.  Work alongside other team members professionally and courteously.  This is a 1st shift position reporting to the team supervisor.

 

Position Requirements:

Physical Requirements:  Must be able to lift up to 40 pounds; Manual dexterity required for operating machinery and computers; Fine motor skills with frequent hand and arm movement.  We are  a Class III medical device manufacturer and are an Equal Opportunity Employer.  We do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

 

Jarvik Heart, Inc. is a privately-held company that develops and manufactures miniaturized heart assist devices for the treatment of severe heart failure. The Jarvik 2000 Flowmaker, Jarvik Heart’s successful pilot heart pump, is an investigational device used in the United States to support patients awaiting heart transplants. In Europe, the Jarvik 2000 has earned CE mark certification for both bridge-to-transplant and lifetime use. As an investigational device, the Jarvik 2000 has been implanted in 800 heart failure patients with no mechanical failures, and has successfully sustained and improved the condition of patients awaiting transplants, as well as those who have chosen the device for lifetime use

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Title Quality Engineer
Categories Manufacturing, Quality Department
Location New York, NY
Job Information

Responsibilities

·         Work closely with Quality System Manager to maintain company Quality System

·         Perform process improvement activities and process validations

·         Perform investigations and corrective actions as necessary

·         Revise Quality System procedures and other documentation as necessary

·         Support development activities under design controls

·         Support annual Quality System inspections and external quality audits

·         Support Quality Manager with Management reviews and maintenance of corrective/preventative action system

·         Support various regulatory and/or clinical activities as necessary

·         Other duties as necessary

 

 Desirable skills

·         Mechanical or industrial engineer with 3–5 years of experience working for a medical device company

·         Enthusiasm for learning and desire to be challenged in a fast-paced medical device company

·         Detailed oriented, good analytical skills

·         Knowledge of FDA, GMPs, ISO 13485, ISO 14971

·         Knowledge in the application of design controls

·         Knowledge of equipment qualifications (IQ/OQ/PQ) and process validations

·         TQM knowledge or ASQC certifications helpful

·         Good technical writing, communication, and interpersonal skills

·         Experience using statistical tools to improve quality

·         Position reports to Quality System Manager

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