Principal Product Engineer, Sb

5 days ago

Singapore A*STAR Agency for Science, Technology and Research Full time

Singapore Biodesign is a national talent development platform for health and medtech innovations with the goal of streamlining the innovation process and assisting to accelerate their pathways to commercialization and adoption.
You will be working in a dynamic environment and a multidisciplinary team in tackling challenging yet rewarding tasks. The Principal Product Engineer will be responsible for conceptualizing and developing MedTech innovation research projects and ideas with the Singapore Biodesign core team, national ecosystem stakeholders and industry partners. You will lead MedTech prototype design, testing and validation in assisting MedTech innovations to startup creation. There is opportunity to participate in special projects related to providing engineering consultancy services to the national ecosystem stakeholders.
- Lead execution of short-term grant projects and/or long-term joint
- collaboration industry projects (est 1-2/ year).
- Work with fellowship teams to brainstorm, generate concepts, build and test prototypes, realize ideas and demonstrate proof of concept.
- Mentor fellowship teams and partners to develop projects that meet commercial objectives, technical requirements and timeline goals.
- Take on engineering consulting roles to provide guidance on prototyping strategies, requirement specifications, traceability, risk management (Hazard Analysis, FMEAs, etc), verification and validation process for startup teams.
- Collaborate with vendors to support internal Software, Electrical, Mechanical and Manufacturing engineering needs.
- Oversee utilization and maintenance of SB prototyping and engineering tools.
- Conduct product development workshop and create learning materials to enhance MedTech innovator’s competencies in medical device development.
- Provide teaching assistance and support operational logistics for SB training activities.

**Qualifications**:

- 8-10years engineering experience in product development with significant hands-on experience in requirement specification, prototyping, design and testing.
- Bachelor’s degree or higher in an Engineering discipline or Physics.
- Excellent communication and presentation skills.
- Evidence of leading novel NPD (new product development) projects from concept through transfer to-manufacture to product launch.
- Direct experience in working within medical / regulated product development process compliant with ISO 13485.
- Experience in creating and updating design documentation (DHF).
- Experience in characterization and testing of medical device or instrumentation systems.
- Excellent collaboration, relationship building, and leadership skills to help team members work toward common goals.
- Strong technical breadth and demonstrated ability to understand and communicate technical information at all levels.
- Solid knowledge of regulatory standards such as ISO13485, ISO14971, 21 CFR Part 11, IEC 60601, IEC 62304 and AAMI standards applicable to medical devices and software.

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