Job Description
Job Description
Job Title: Systems Engineer - Lotus Project
Location: Oro Valley, AZ, 85755
Duration: 18 Months contract
Pay - $45/hr on W2
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.
Company DescriptionStaffing Company (Confidential)
Company Description
Staffing Company (Confidential)