Job Description: R&D Solution Architect (Biomedical)
The R&D Solution Architect in Biomedical Technologies plays a pivotal role in shaping the future of healthcare through innovative biomedical technologies. Reporting directly to the Head of Strategic Initiative, this position requires a highly skilled professional capable of leading a cross-functional technical team in the conception, development, and commercialization of cutting-edge biomedical diagnostic tools. As the R&D Solution Architect for biomedical technologies, your role would be to bridge across the understanding of the basic scientific principles involved in the biological processes and operation principles of the medical devices, to translate these needs and constraints into well-articulated technical requirements and parameters of the proposed innovative medical technologies, all whilst balancing the cost and manufacturability of the solutions to match production processes and commercial needs of the company. Hence the ideal candidate should possess a deep understanding of biomedical engineering principles, a successful product development track record, and exceptional leadership skills to inspire and motivate the teams.
Responsibilities
Research
- Perform comprehensive literature reviews of key technology concepts related to biomedical diagnostics.
- Identify emerging technologies and trends in the biomedical and microfluidics field and assess their potential impact for market disruption.
- Conceptualize and design system architecture of novel biomedical technologies to address market needs.
- Develop deep understanding of cause-effects relationship for underlying working principles of proposed innovation, based on relevant scientific literature and system engineering methodologies.
- Design and plan experimental procedures to validate hypotheses, identify issues, and propose solutions for workarounds.
Development
- Lead the conception and development of new biomedical products, from ideation to market launch.
- Oversee the entire product development lifecycle, ensuring adherence to timelines, budgets and quality standards.
- Coordinate with multidisciplinary teams, including engineers, scientist, clinicians, and regulatory affair specialists, to bring products to market.
- Ensure all biomedical products and solutions comply with relevant regulations and standards.
Leadership
- Foster a culture of innovation with foresight within the team, encouraging creative thinking yet measured risk-taking among team members.
- Build and maintain strong relationships with key stakeholders, including investors, customers and partners.
- Represent the organization at industry conferences, seminars, and meetings to promote its innovations and establish thought leadership.
Education and Experience Required
- PhD or Master's degree in Science, Biomedical, Engineering or a related field.
- Proven experience in developing complex biomedical diagnostic tools from concept development to market launch.
Knowledge and Skills
- Exceptional critical analytical thinking skills, adept at analysis, and proficient in problem-solving.
- Exceptional leadership with the ability to inspire and motivate teams towards innovation.
- Ability to clearly and precisely communicate complex and abstract ideas, excel in managing multifaceted project objectives and possess strong verbal and written communication skills, negotiation abilities, presentation skills, and stakeholder influence.
- Ability to navigate complex regulatory environments and compliance standards.
- Entrepreneurial mindset, with experience in identifying and capitalizing on new opportunities.
- Knowledge and experience of international quality standards for development of medical devices such as ISO13485 and ISO14971.
- System decomposition and setting up test plans for early- mid- and late-phase product development such as the V-model for verification and validation of medical devices.
- Experience with application and coaching of multidisciplinary teams on engineering methodologies such as Design for Six-Sigma in complex product development projects.
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