Jobs Listing

Please find below the list of positions for which Jarvik Heart, Inc. is currently accepting applications.
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Related Categories

Engineering, Manufacturing, Quality Department, Production, Assembly
Title Electronics Assembler
Categories Assembly, Manufacturing, Production
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

 

Apply Now


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

 

Apply Now


Title Mechanical Assembly Technician
Categories Assembly, Manufacturing, Production
Location New York, NY
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

–    Deburr 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

 

Apply Now


Title Quality Engineer
Categories Engineering, 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

Apply Now


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