Job Description

This is an onsite position for a motivated, hands-on engineer who has experience with electro-mechanical devices.

Required Skills/Experience:

Job Description:

**Experience in front-end Systems Engineering design & development deliverables around

requirements, risks & architecture.

**Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade off analyses

**Experience in a regulated medical device industry

The Position:

Tissue Diagnostics is seeking a Systems Engineer to drive product definition, including

requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the-art testing automation, providing over 250 cancer tests and associated instruments globally.

Responsibilities:

--System Lifecycle Management: Apply Systems Engineering to product definition,

requirements, risk analysis, and testing.

--Project Execution: Manage requirements, risk analysis, and verification/validation.

--Industry and Technology Analysis: Research trends, emerging technologies, and competitive products' differentiation.

--Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and

Regulatory teams to ensure alignment.

--Customer-Focused Innovation: Engage with business leaders and VoC representatives to

align technical solutions with customer needs.

--Technical Problem Solving: Analyze complex technical challenges, present solutions, and

facilitate informed decision-making.

Who You Are:

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

--Systems Engineering Expertise: Demonstrated knowledge in systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA

--Regulatory Familiarity: Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.

--Strategic Mindset: Interest in innovative technologies and understanding of the IVD competitive landscape.

Preferred:

--Specialized Skills: Deep knowledge in reliability, manufacturability, and usability.

--Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.

--Organizational Skills: Excellent organizational skills, capable of evaluating, prioritizing, and

managing multiple projects efficiently.

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