Manufacturing

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Engineering, Manufacturing, 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

 

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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 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.

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