Senior Engineer, Mechanical, MedTech Catapult

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 90,000 - 180,000; Full time

Job summary

A*STAR Research Entities in Singapore invites an experienced Mechanical Engineer to design and develop medical devices from concept to pilot production. You will build functional prototypes in a lab and test environment and produce high-quality drawings and assembly specifications.

You will plan verification and validation activities, support manufacturing with pilot equipment and processes, and collaborate with vendors while ensuring compliance with quality systems.

Qualifications

• Minimum 5 years of experience in design and development of medical devices/life science instrumentation.
• Proficiency with SolidWorks or equivalent CAD software.
• Strong problem-solving and leadership abilities.
• Experience with design for manufacturing and V&V planning.

Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Design, develop and test devices by building functional prototypes in a laboratory and test environment.
• Produce high-quality engineering drawings and assembly specifications.
• Plan and perform verification and validation activities to ensure requirements.
• Collaborate with outside vendors on design, materials, and processing.
• Prepare documentation to support quality systems for design functions.

Skills

Mechanical design

Prototyping

Leadership

Interpersonal skills

Education

Bachelor’s or Master’s degree in Mechanical Engineering

Tools

SolidWorks

MS Office

Job description

Job Responsibilities

• Develop and engineer novel medical technology products from concept to pilot production.
• Design, develop and test devices by building functional prototypes in a laboratory and test environment.
• Production of high-quality engineering drawings and assembly specifications.
• Develop feasibility and reliability testing plans, including the development and validation of accurate in-vitro and in-vivo models and methods.
• Plan and perform verification and validation (V&V) activities and documentation to ensure compliance with requirements.
• Support development of intellectual property portfolio in device design and process technology know-how.
• Prepare and support product development and quality planning (project schedule, resources, budgets, etc.).
• Work on design for manufacturing by designing and developing pilot manufacturing equipment and procedures whilst assessing feasibility of processes and support manufacturing with validation plans and time studies.
• Collaborate with outside vendors on the design and sourcing of materials, components, and processing.
• Prepare documentation to support quality system for design functions (concept document, risk analysis including FMEA, design input, design output, test results, drawings, etc.).
• Complete activities according to project phase checklists.
• Review document changes in manufacturing for impact on design intent.
• Interact closely with engineers from other disciplines to achieve an optimized design within the stipulated project schedule.
• Provision of technical input to help identify and mitigate project risks affecting project schedules and plans.
• To support other activities for product engineering when required.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering or related fields.
• Minimum 5 years of experience in the design and development of medical devices/life science instrumentation.
• Proficiency in computer applications, including MS office, SolidWorks or alternative CAD software.
• Prototyping and materials knowledge for medical devices
• Experience with FDA 21 CFR Part 820 and ISO 13485 quality management and regulatory requirements.
• Experience in the design of electromechanical motion systems, fluidics and optics is a plus
• Experience in thermal management simulation and electromagnetic enclosure shielding design is a plus.
• Experience in material selection and biocompatibility is a plus
• Strength in problem-solving and decision-making
• Highly motivated, attention to details and a sense of urgency
• Highly organized, proactive, and effective in collaborating across cross-functional teams.
• Demonstrate strong interpersonal skills and leadership skills

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.