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R & D Engineer
Résumé du poste
A leading engineering firm in Singapore seeks a qualified professional for test verification and validation in the Medical Device sector. Candidates should possess a degree in engineering and relevant experience in design verification activities, especially within regulated industries. Responsibilities include developing test plans, managing testing labs, and ensuring compliance with regulatory standards. Strong problem-solving skills and proficiency in statistical software are essential for success in this role.
Qualifications
- 3-5 years of relevant experience in a regulated industry.
- Knowledge of design verification and validation processes.
- Good understanding of DOE (Design of Experiments) principles.
Responsabilités
- Develop test plans and protocols for design verification.
- Manage R&D prototype and testing lab operations.
- Conduct feasibility testing in collaboration with development teams.
Connaissances
Formation
Outils
- Develops and conducts test plans and protocols for design verification, process characterization, process validation, finished product and benchmarking study to generate test reports with engineering principle.
- Manage R&D prototype and testing lab, participate prototype & testing lab budget management.
- Maintain the equipments and tools and monitor regular required calibration, qualification.
- Design, develop, and implement automated and manual test procedures for functional, performance, and regression testing.
- Identifies and consolidates requirement lists from product performance, functional and regulatory aspects.
- Drives the entire design verification and validation activities to ensure compliance to regulatory requirements such as IEC, FDA, GMP, ISO and IEC standards.
- Develops and executes various benchmark testing to understand product quality compared to existing products.
- Develops and validates new equipment and fixtures to conduct various testing.
- Conducts feasibility testing together with product development and quality team.
- Liaise with external test labs to obtain critical data for test reports.
- Work with equipment vendors to identify test equipment that meets testing requirements.
- Identify, document, and track defects using issue tracking tools.
- Work closely with development teams to identify and address potential issues early in the development lifecycle.
- Communicate all identified risks to your Test/Team Lead.
- Summarizes test report and present to project and management team.
- Perform other tasks as assigned by the supervisor.
- Degree or Master in Mechanical Engineering, Electrical or Material Science / Bio Engineering or related field.
- Min 3-5 years relevant experience, preferably in Medical Device, Automotive or Aerospace industry.
- Preferably 1-2 years of relevant experience in design verification and validation of Medical Device or other highly regulated industries.
- In-depth knowledge of test and design verification methodologies, regulatory standards/environment requirements and required documentations.
- Good understanding of DOE (Design of Experiments) principles.
- Good command of Minitab or other statistical analysis software.
- Excellent problem-solving and debugging skills.
- Proficiency in test automation tools and scripting languages.
- Have good understanding of cybersecurity requirements for medical device testing.
- Good time management skills, including the ability to prioritize work and meet deadlines.
- Strong interdisciplinary communication skills with internal and external stakeholders (customers, project, development, quality, and regulatory teams).
- Working location at Tampines Area.
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.