Systems Engineer - Assay Development

Job Title

Responsibilities include:

System Lifecycle Management: Apply broad knowledge and skill-sets from Systems Engineering, focusing on the requirements engineering, risk management, and verification & validation stages of the system lifecycle.

Industry and Technology Analysis: Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies.

Cross-functional Collaboration: Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements, particularly regarding traceability, risk, and validation.

Customer-Focused Innovation: Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess associated risks, and define appropriate validation criteria.

Technical Problem Solving: Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address requirements definition, risk mitigation, and verification & validation challenges.

Project Execution: Execute project deliverables specific to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in the company-specific tool.

Who You Are

Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD).

Experience in assay development at a medical device company.

Systems Engineering Expertise: Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.

Regulatory Familiarity: Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products, especially regarding requirements, risk, and validation.

Strategic Mindset: Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation approaches.

Preferred

Knowledge of Cytology assay development in clinical workflow setting. Familiarity with various cytological techniques and their applications.

Specialized Skills: Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development.

Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills, particularly in facilitating discussions around complex requirements, risks, and validation plans.

Organizational Skills: Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner, especially in managing extensive requirement sets, risk registers, and verification & validation matrices.

Assay Development: Familiarity with the assay development process and its associated requirements, risks, and validation needs.

Technical Tools: Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart.

Advanced Knowledge: Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry, to better define requirements, assess risks, and plan validation across system components.