Research And Development Engineer

3 days ago

Klang, Selangor, Malaysia Hays Full time

New Product Introduction (NPI) & Process Engineering, Engineer [2 Vacancies]

  • Translate customer requirements into internal specifications and develop new product specifications.
  • Design and validate manufacturing processes (automated/semi-auto/manual), tools, jigs, and fixtures.
  • Prepare documentation including BOMs, test methods, SOPs, and process flow diagrams.
  • Conduct process cycle time calculations and line balancing for new manufacturing lines.
  • Support production teams with troubleshooting, process optimization, and training on new processes.

Quality Validation & Compliance Engineer [1 Vacancy]

  • Manage validation activities including equipment, process, and test method validations.
  • Develop and execute stability and transportation studies as per customer requirements.
  • Maintain and review validation master lists and conduct periodic validation reviews (PVR).
  • Administer and ensure proper operation of test equipment (e.g., tensile tester, smart scope).
  • Lead non-conformance investigations, root cause analysis, and implement CAPA.
  • Support internal, supplier, and external audits and ensure compliance with ISO 13485, GMP, and FDA 21 CFR Part 820.

Continuous Improvement & Technical Support

  • Analyze manufacturing data for capability studies and risk assessments.
  • Revise specifications and manage customer change requests.
  • Stay updated with new technologies and provide technical support for product and process improvements.

Requirements:

  • Bachelor's Degree in Engineering, Science, Chemistry, or related field.
  • Minimum 3 years of experience in the
    Medical Device
    or
    Pharmaceutical
    manufacturing industry.
  • Strong knowledge of
    ISO 13485
    ,
    GMP
    , and
    FDA 21 CFR Part 820
    .
  • Experience in cleanroom environments is highly preferred.
  • Proficient in CAD/SolidWorks and statistical analysis tools.
  • Excellent communication skills in English and Bahasa Malaysia.
  • Strong problem-solving, project management, and interpersonal skills.
  • Proactive, resourceful, and able to work independently and in teams.
  • Computer literate (Microsoft Office, data analysis tools).

What's in it for you:

  • Be part of a growing and innovative medical device company.
  • Work in a collaborative and regulated environment.
  • Opportunity to lead impactful projects from concept to commercialization.
  • Competitive salaries up to 7-8k MYR.

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