Background information about the job or company

This role is intended for a technical research and design leader capable of driving product development execution within a fast-moving stringently regulated startup environment. The Research and Development Director will lead the development and lifecycle management of Microhaem Scientific`s medical devices and serve as the device subject matter expert (SME) across new product development, systems integration, design controls, risk management, and verification & validation activities associated with Microhaem Scientific`s product portfolio. This role requires a strong systems thinker, a highly capable technical contributor, experienced in stringently regulated medical product development, comfortable operating across software and hardware boundaries, and capable of directly driving research and development. The Director of Research and Development Director will work closely with Regulatory Affairs, Quality Management Systems, Manufacturing, Clinical, and Operations teams to improve and expand Microhaem Scientific`s current product platform while supporting commercialization readiness and future product innovation.

Responsibilities or duties

A. Product Development & Technical Leadership

• 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 or requirements

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

Experience needed

10+ years of experience in medical device research and design. Startup medical device company experience strongly preferred.

• 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
• 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
• 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.

• Strong leadership skills and ability to collaborate effectively with team members
• 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
• 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

• 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 design.
• Strong experience with point of care tests including rapid diagnostic tests.
• Startup medical device company experience strongly preferred.
• Understanding of ISO 13485 and stringent medical device regulations including