Systems Engineer VI

This is a fully remote position, open to applicants in California.

📋 Description

• Lead and execute product definition, system architecture, requirements documentation, requirements management, requirements analysis, risk assessment, hazard analysis, product testing and evaluation, and/or design control documentation.

• Oversee the development of design processes.

• Direct the integration of analytical and performance-related elements with software, hardware, and electronic system components.

• Provide technical guidance to project teams.

• Effectively communicate and engage with cross-functional development teams, demonstrating strong negotiation skills to guide multi-disciplinary teams toward solutions.

• Accountable for utilizing and maintaining the effectiveness of the quality system. Inadequate definition of requirements, integration of all systems, and verification/validation of requirements could lead to product launch delays and quality concerns.

• Collaborate with our customer's product managers to identify, comprehend, and convert business needs into technical requirements.

• Ensure that requirements are thoroughly understood and that implementation plans align with expectations by working closely with both internal and external teams, including multi-disciplinary engineering teams, quality assurance, operations, and regulatory bodies.

• Act as our product expert by providing training to internal staff and customers on product usage, addressing inquiries regarding the product and its features, and evaluating and mitigating technical risks.

• Function as a product advocate and subject matter expert.

• Lead the generation and upkeep of appropriate product documentation.

⛳️ Requirements

• Bachelor's or Master's degree in an engineering or scientific field.

• A minimum of 10 years of experience in product development.

• Comprehensive understanding of general engineering/science principles and laboratory techniques.

• Strong familiarity with development processes that adhere to ISO and FDA design control standards or requirements.

• Knowledge of current design control and risk management practices.

• Experience in one or more of the following areas: Electro-mechanical, software, mathematical, chemical, or biochemical technologies related to the design, integration, evaluation, and commercialization of diagnostic systems.

• Excellent verbal and written communication skills with the ability to convey information effectively across various organizational levels.

• Capable of managing multiple subjects simultaneously.

🏝️ Benefits

• Competitive salary package.

• Comprehensive health benefits.

• Opportunities for professional development and training.

• Supportive work environment that encourages innovation.