Key skills
Risk Management
About this role
Role Overview
- Lead/Perform product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, hazard analysis, product test and evaluation, and/or design control documentation.
- Lead the development of design processes.
- Lead integration of analytical and performance related elements with software, hardware, and electronics system components.
- Provide technical direction to project teams.
- Communicate effectively and participate on cross functional development teams with good negotiating skills to direct multi-disciplinary teams toward solutions.
- Responsible for utilizing and maintaining the effectiveness of the quality system. Failure to properly define requirements, integrate all systems, verify/validate requirements could result in product introduction delays and quality issues.
- Work with our customer's product managers to uncover, understand, and translate business needs into technical requirements.
- Ensure requirements are fully understood and that implementation plans match expectations by working well with internal and external teams, including multi-disciplinary engineering teams, quality assurance, operations, and regulatory.
- Operate as our product expert by providing internal and customer training on how to use the product, answering incoming questions about the product and its capabilities, assessing and addressing technical risk.
- Serve as a product evangelist and subject matter expert.
- Lead the creation and maintenance of proper product documentation.
Requirements
- Bachelors or Master's degree in an engineering or scientific discipline.
- Minimum 10 years of product development experience
- Solid knowledge of general engineering/science principals and laboratory skills.
- Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.
- Knowledge of contemporary design control and risk management practices.
- Experienced in one or more of the following: Electro-mechanical, software, mathematical, chemical or biochemical technologies as they pertain to the design, integration, evaluation and commercialization of diagnostic systems.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Ability to work on many subjects concurrently.