Jobs Listing

Please find below the list of positions for which Jarvik Heart, Inc. is currently accepting applications.
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Manufacturing, Engineering, Quality Department, Research and Development
Title Machinist I
Categories Manufacturing
Salary based on experience
Start Date 2021-12-01
Location New York, NY
Job Information
Main Duties & Responsibilities, General:

Support manufacturing at Jarvik Heart, Inc. by machining 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
  • Program CNC machines (requires working with Engineers, Staff, and Designers, as well as trouble-shooting programs and fixtures)
  • Applicants should be highly proficient programming and using MasterCam
  • Proficient on 4 & 5 axis mills, wire EDMs, and manual lathes
  • Inspect products using calipers, micrometers, optical comparators, multi-meters, oscilloscopes and other measurement devices as applicable
  • Complete necessary documentation accurately and legibly
  • Use and maintain equipment and fixtures, and other equipment as required
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 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 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, ISO 13485, ISO 14971, GMPs

·         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 Assurance Manager

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Title Quality Assurance Inspector
Categories Quality Department
Salary based on experience
Location New York, NY
Job Information

Quality Assurance Inspector

  • Work in manufacturing and production environment
  • Be responsible to inspect, test, sample and sort small high precision machined parts and electromechanical assemblies.
  • Perform 1st piece inspection, in-coming inspection of material and components, in-process inspection and finished goods inspection.
  • Show proficiency and understand manufacturing drawings and tolerances and ISO/ ANSI standards
  • Operate inspection tools including calipers, micrometer, go/no-go gauge, thread gauges etc.
  • Review and follow internal work instructions and procedures, qualifications and validations written by the company and will document the results.

 

Position reports to Quality System Manager

Education

  • 2 years experience in the same environment industry or similar.
  • A High School Diploma or GED is required to fulfill this job opening. Associate degree is preferred. Experience working in a GMP environment helpful

Jarvik Heart, Inc. is a private company that develops 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 more than 700 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 Electrical/Electronics Engineer
Categories Research and Development
Job Information

Electrical/Electronics Engineer with 5+ years of experience to work in a small team dedicated to sustaining existing and developing next generation circulatory support systems. Substantial experience with analog, digital and DC power circuits required.

Experience with electronic commutation of dc motors, Lithium-ion battery management technology, and embedded micro-controllers is beneficial.

Experience working under a formal quality management system and on medical designs is a plus.

The ideal candidate will:

-Assess system needs and detail electrical and interface requirements
-Produce designs based on the assessment of requirements
-Participate on cross-functional teams to assess design requirements and participate in system design
-Design test methods and participate in verification testing of components, subassemblies and systems
-Comply with company procedures, international standards and regulations regarding design control
-Complete PCB design and troubleshooting
-Develop manufacturing processes by designing and modifying equipment for building and assembling electrical components
-Prepare product reports by collecting, analyzing, and summarizing information and trends
-Complete projects by training and guiding production personnel
-Provide engineering support and troubleshoot legacy hardware
-Contribute to team effort by accomplishing related tasks as needed

Desired skills and qualifications:

– BLDC sensor-less motor commutation
– Analog circuit design and troubleshooting
-PCB design
-Battery management (lithium-ion) circuitry
-Embedded systems
-Microcontrollers
-Testing
-Software Proficiencies: MS Office, EAGLE (other similar CAD), LABVIEW, MS Project,
embedded-C (e.g. PIC, AVR. . .)
-Standards: ISO 13485, IEC 60601-1, ISO 14971, IEC 62133

A bachelor’s degree in electrical engineering or a related field is required or substantial experience.

This position reports to the Research and Development Manager.

Company description

Jarvik Heart, Inc. is a private company that develops 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 more than 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.

Apply Now


Title Manufacturing Engineer
Categories Engineering, Manufacturing
Location New York, NY
Job Information

Position directly supports the manufacturing and assembly of medical devices.  Experience working within a quality management system or in the medical device industry is helpful.  Must be able to work productively in a busy manufacturing environment with numerous distractions and show an eagerness to learn and work on a close-knit team while energetically and proactively supporting a dynamic, growing, regulated company.

Desired skills and qualifications:
– Strong organizational skills with attention to detail

– Manufacturing engineering experience of 2 years or more is desired

– Electrical engineering degree or experience is helpful

– Very good written and verbal communication skills

– Proactive and energetic (a self-starter)

– Works well in a group

– MS Office (MS Excel, MS Word, MS PowerPoint)

A degree from an accredited college or substantial engineering experience (manufacturing/mechanical/electrical), is required.

This position reports to the Manufacturing Manager.

Apply Now


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