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Manufacturing, Engineering, Quality Department, Assembly, Production
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 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

 
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, 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
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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