Lead/principal Engineer, Material
1 week ago
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.
- 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.
**Type of Employment**: Full-Time
**Minimum Experience**: 10 Years
**Work Location**: Biopolis
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