Lead end-to-end product development initiatives from concept through commercialization in accordance with WHO standards, ISO 13485, ISO 14971, and IEC
Translate user needs into product requirements and executable development plans with defined milestones, timelines, and risk mitigation strategies
Implement sustainable research and design and product improvement activities for existing commercial-stage products.
Drive system-level design architecture, integration strategy, and research and design decision-making.
Ensure systematic and compliant execution of SRA-compliant design controls and
Support development and execution of verification & validation
Lead technical troubleshooting, root cause investigations, and field issue
Support manufacturing supplier management and design transfer
Support regulatory submissions and health authority interactions

B. Cross-Functional Collaboration

Support technical documentation development for regulatory submissions and regulatory
Collaborate closely with Regulatory Affairs and Quality on design and development file (DDF) development, risk management, Verification & Validation, and change control
Lead research and design activities associated with IEC 60601, IEC 62304, ISO 14971, and Human Factors Research and
Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data
Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the

C. Leadership & Team Development

Lead and mentor team
Help establish a high-performance research and design culture centered around accountability, technical rigor, and execution
Coordinate internal research and design resources and external development
Support recruiting and development of future research and design
Collaborate cross-functionally across R&D, Quality, Manufacturing, Clinical, and Operations.

QUALIFICATIONS & EXPERIENCE

A. Requirements

Master’s degree in Biomedical Research and design, Electrical Research and design, Systems Research and design, or related field PhD is preferred.
10+ years of experience in medical device research and
Strong experience with point of care tests including rapid diagnostic ests,
Startup medical device company experience strongly
Understanding of ISO 13485 and stringent medical device regulations including

B. Preferred skills

Strong leadership skills and ability to collaborate effectively with team members and Familiarity with medical device research and design concepts, test methods, equipment and applicable national and international standards relating to testing ISO 13485, WHO and other stringent regulatory authorities (SRAs).
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in scientific form and deal with several abstract and concrete
Ability to comprehend and communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by
Strong systems-level technical
Excellent communication and leadership
Hands-on research and design
Strong organizational and prioritization
Comfortable operating in rapidly evolving
Ability to independently drive technical
High-accountability builder
Hands-on, driven work ethic and entrepreneurial

C. Computer Software / Programs

- Proficiency with Microsoft Office and technical presentation
- Experience with eQMS and requirements/risk management
- Familiarity with, statistical tools, and modern research and design collaboration platform

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