Systems Engineer

Only local candidates

No 3rd party agencies! Direct W2 contractors only!

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

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.

Skills required:

--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.