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A leading company is seeking a Lead/Principal Engineer for the MedTech Catapult initiative in Singapore, responsible for developing high-value medical technology products. This role requires extensive experience in materials science and a strong background in regulatory compliance within the medical devices sector. The engineer will mentor junior staff and collaborate with cross-functional teams to ensure successful project outcomes.
Lead/Principal Engineer, Material, MedTech Catapult
MedTech Catapult is a national initiative for accelerating the development of high-value MedTech projects through an in-house product engineering unit. This productization unit is responsible for supporting the development of technologies through the medical device development cycle to produce full-fledged hardware product systems. The Lead Engineer will report to the Lead, Product Engineering.
Industry
Medical Devices, Life Science Instrumentation, Advanced Materials
Employment Type, Location
Full-time, Singapore
Job Function and Seniority Level
Lead/Principal Engineer
Job Responsibilities
· Develop and engineer novel medical technology products from concept to pilot production.
· Evaluate novel materials for integration into early- to late-stage product development, including polymers, metals, ceramics, coatings, and composites.
· Lead materials selection and development for medical device components, ensuring biocompatibility and regulatory compliance.
· Assess and qualify material suppliers and support sourcing
· Design, develop and test devices by building functional prototypes in a laboratory and test environment.
· Guide material characterization and testing (mechanical, thermal, chemical, and biological), including specification development and failure analysis.
· Manage and assist with verification and validation activities and documentation
· Work closely with QA/RA to align materials with FDA CFR 820, ISO 10993, and ISO 13485 requirements.
· Contribute to feasibility, reliability, and manufacturability assessments from a materials perspective.
· Collaborate with internal cross-functional teams and external partners to achieve optimized designs within project timelines.
· Provide mentorship and guidance to junior engineers in materials engineering.
· To support other activities for product engineering when required.
Requirements
· MSc or PhD in Materials Science, Biomedical Engineering, Chemical Engineering or related field.
· 10 years of experience in medical device materials development, testing, and regulatory compliance.
· Deep understanding of biomaterials, polymers, elastomers, and coatings for medical applications.
· Experience with FDA and ISO standards relevant to materials (e.g., ISO 10993, ISO 13485, USP Class VI).
· Skilled in using materials characterization tools (e.g., DSC, TGA, SEM, FTIR, tensile testing).
· Strong working knowledge of SolidWorks or equivalent CAD tools is a plus.
· Experience in design for manufacturability and scaling of material-related processes.
· Excellent problem-solving, decision-making, and analytical skills.
· Strong interpersonal and collaboration skills; detail-oriented and proactive.
· Demonstrated leadership experience in cross-functional engineering teams.