Product Development Engineer - new job in Boston, US

Product Development Engineer
  • $30 - $50 per Hour
    HOUR
  • Temporary
  • Boston MA, US Boston SUFFOLK US 02127
Job Ref: JO000134136
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 15 November 2022

Location: Mansfield, MA –JO000134136

Consultant Title: Product Development Engineer EU MDR

Duration: 6 + Months

Day to day responsibilities:

  • Understanding of Medical Device-New product development and Sustaining Engineering Process,
  • Working knowledge of Technical files and Medical Device product development process,
    Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process,
  • Experience in Remediation of QMS, Tech File, DHF and Risk Management File,
  • Understanding of Medical regulatory standards is preferred (EU Regulations – MDD & MDR)
  • Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971,
  • Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes,
  • Experience in creation of Protocols, Testing and Verification including product usability is required,
  • Hardworking and should be individual in design activity and Problem-solving skills,
  • Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors,
  • Experience with MS Project, MS Office

Qualifications:

  • Experience: minimum 5 years’ experience in mechanical design, new product development of medical devices, or sustaining engineering
  • Education: Bachelor’s degree in Mechanical Engineering or similar engineering discipline (Master’s degree in mechanical or biomedical engineering preferred)
  • Experience in EUMDR product remediation is a plus

SRG ED&I and EEO Statement

• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.

• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#IND-P1

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/srg-impellam-lock-up-logo---large.png
20/12/2022 12:00:00
USD 30.00 50.00 Hour
Contact Consultant:
Kristen Wojtkowiak

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