Systems Engineer - Lotus Project

Introduction

This position involves front-end Systems Engineering design & development deliverables related to requirements, risks, and architecture. The Systems Engineer will work independently and collaboratively with various groups to gather needs and conduct trade-off analyses. Experience in a regulated medical device industry is essential for this role.

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.

Requirements

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.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”