R & D Engineer

MASS POWER SERVICES PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

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.

Responsibilities

• Develop test plans and protocols for design verification.
• Manage R&D prototype and testing lab operations.
• Conduct feasibility testing in collaboration with development teams.

Skills

Test verification methodologies

Problem-solving skills

Statistical analysis software (Minitab)

Test automation tools

Time management

Interdisciplinary communication

Education

Degree or Master in Mechanical Engineering, Electrical or Material Science / Bio Engineering

Tools

Minitab

Job description

Responsibilities

• 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.

Requirements

• 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.