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Project Engineers Full-time

at MEDCHEM ENGINEERING SERVICES New York in New York (Published at 09-06-2022)

MedChem Engineering Services is an engineering firm specialized to provides a complete range of professional services to pharmaceutical and medical devices clients. MedChem operates in Puerto Rico. For more information, please visit our website: www.medchemengineeringservices.com

SUMMARY OF JOB FUNCTION

This position is responsible to perform the tasks assigned by the Engineering Department under the EU MDR Program across the medical device industry.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
  • Must have knowledge of ISO 11607 regulations for sterile barrier packaging.
  • Must have a thorough understanding of packaging and transit (transport) testing and performance test methods (conditioning, compression testing, drop testing, vibration testing, bubble leak test, among others).
  • Must have knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation.
  • Must have knowledge and working experience in package and sealing integrity tests as well as package seal strength tests such as: seal strength (peel) test, burst test, creep test, bubble leak test and dye penetration, among others.
  • Experience with managing documents within electronic PLM system.
  • Experience with working with cross functional team.
  • Experience in Design Control procedures and regulation is desirable.
  • Experience in New Product transfer into Manufacturing (Design Transfer) and Design Controls desired.

EDUCATION AND EXPERIENCE

  • Bachelor's degree on a relevant engineering field as Chemical Engineering, Industrial Engineering, Mechanical Engineering, Electrical Engineer or Biomedical.
  • Minimum of 3 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.

Fully Bilingual

Job Types: Full-time, Contract, West Area

Job Types: Full-time, Contract

Schedule:

  • Monday to Friday

COVID-19 considerations:
Candidates must be vaccinated for COVID-19

COVID-19 considerations:
Please, visit www.cdc.gov for guidance on a variety of topics to help prevent the spread of COVID-19.

Education:

  • Bachelor's (Preferred)

Work Location: One location



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