snr / product safety & compliance engineer (r&d) in Singapore

posted
contact
yit wei kwan, randstad
job type
permanent
salary
S$ 4,000 - S$ 7,500 per month

job details

posted
location
singapore
specialism
manufacturing & production
job type
permanent
working hours
Full-Time
salary
S$ 4,000 - S$ 7,500 per month
experience
4 years
reference number
91M0158529_1626585887
contact
yit wei kwan, randstad
phone
65103642
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job description

about the company

My client is a dedicated medical device manufacturing company.This well-recognised brand offers a great working environment in brand new offices.

about the job

  • Defining the applicable safety and regulatory standards for an assigned product
  • Support in the creation and maintenance of Declaration of Conformity
  • Lead the effort in complying with IEC 60601-1
  • Providing input on the applicable codes and safety standards for the development of medical devices
  • Obtaining and maintaining 3rd party Product Certifications
  • Creation and maintenance of Clinical Evaluation Reports

skills & experience required

  • Master / Bachelor Degree in Engineering
  • Min 5 years of experience in product safety in a R&D manufacturing environment
  • Hands on with medical Devices safety (IEC 60601-1), FDA Regulations compliance will be a plus
  • Able to translate safety standards clauses to technical design requirements
  • Knowing of medical device software life cycle processes (IEC 62304), EMI/ EMC requirements, Mattress Flammability, E&L, REACH, ROHS and Biocompatibility will be a plus
  • Able to coordinate with relevant parties in conducting product certifications and safety test execution
  • Willing to work in north part of Singapore (Yishun / Woodlands)

If you are interested in the position , kindly send your CVs in to yitwei.kwan(@)randstad.com.sg

Please include your availability, expected salary and reason for leaving current job.

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913

skills

IEC 60601-1

qualification

Degree

educational requirements

Bachelor Degree