SUMMARY:
This position supports managerial, scientific, and technical aspects of assigned projects at Innovenn, Inc. This position provides expertise in medical device development with an emphasis on risk management and validation of risk mitigations for medical devices with Human Factors. In addition, management support and techniques is provided to assigned teams. Independent judgment is required to plan, prioritize and organize diversified workload.
MINIMUM EDUCATION, SKILLS, AND EXPERIENCE REQUIRED:
- Bachelor’s degree in Bioengineering, Biomedical Engineering, or similar, closely related field;
- One year of scientific and/or biotechnology/medical device development experience, including experience in device test development or a Master’s degree in Bioengineering, Biomedical Engineering, Biomedical Innovation Development, or a similar, closely related field.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
[30%] Conducts research along with other life scientists and medical scientists, on Human Factors engineering for medical products to demonstrate medical device safety, efficacy, and effectiveness when used by the intended user. This includes research for development, validation, and verification of new products and expansion of existing products. May maintain databases of the experiments and results.
[10%] Assists with developing overall project timelines, detailed product designs, and performance evaluation strategies that integrate steps for discovery, development and testing of prognostic, diagnostic and predictive medical device across disciplines to provide highest quality solutions to clients.
[10%] Contributes to the writing of project plan documents (e.g., timelines, deliverables, and project requirements) and scientific summaries as needed, (e.g., plan documents, test procedures, protocols, and validation reports) ensuring accuracy, consistency and timely information capture and reporting. This includes writing documents describing protocols, policies, and standards/ Instructions for Use (IFU) (e.g., user manuals) and maintenance of medical devices. Contributes to technical reports, data summaries, research articles for scientific publications, and regulatory submissions.
[10%] Supports medical device regulatory application filings in collaboration with quality and regulatory staff through implementation of research plans, compliance with regulations, and ensuring accurate documentation of the design history of medical device products as appropriate.
[10%] Interfaces with clients, vendors, sub-contractors, and other project team members to understand the scope of work and provide the best solution. Communicates with clients, vendors, subcontractors and other project team members regarding the design or specifications of medical devices and/or medical device software instrumentation. May serve as client liaison and/or team leader, as assigned, to provide support and direction to team including facilitating on-site visits, cross-functional team leadership, and client communications as well as project budget adherence including planned corrective actions, as needed.
[10%] Assists with designing or developing medical devices (e.g., diagnostic, prognostic, or treatment support) using the principles of engineering and/or behavioral science in collaboration with other life scientists, medical scientists, hardware and software scientists to deliver the most desired solutions supporting delivery of quality outcomes.
[10%] Communicates with hospital administrators on acquisition and use of approved medical devices and/or medical device software and may provide onboarding (e.g., training) to educate clinicians and support staff on proper use.
[5%] Demonstrates proposed solutions by developing documentation, flowcharts, layouts, diagrams, and charts, statistical models or simulations, as well as hardware concepts, hardware selection processes, optimization, etc., documenting project decisions and methodologies. Proposes algorithmic solutions and trade-off analysis to problems presented by vendor, other engineers, customers, etc., including the entire process from problem definition to pertinent concepts and solutions to facilitate project outcomes and goals.
[5%] Assists with the identification and management of key vendors to create the design appropriate specifications, execute implementation, and establish quality control of all product features suited to specific disease indications ensuring all client and project goals, product specifications and deadlines are met.
OTHER DUTIES AND RESPONSIBILITIES:
- Assists with the design, development and conduct of Human Factors testing for a variety of types of products. Interfaces with clients, user participants and team members. Provides an overview to user participants ensuring compliance to the test protocol and procedures are maintained during the testing sessions.
- Participates in the development, periodic review, and applicable revisions of departmental and/or cross-functional policies and SOPs to assure compliance with corporate policies and regulations, as needed.
- Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participate in educational opportunities; read professional publications; maintain personal networks; participate in professional organizations.
- Adheres to stated policies and procedures relating to health and safety, and quality management ensuring highest quality project deliverables to clients.
