Systems Engineer - Lotus Project jobs in United States
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Planet Pharma ยท 7 hours ago

Systems Engineer - Lotus Project

Planet Pharma is focused on advancing cancer diagnostics through innovative testing technology. They are seeking a Systems Engineer to drive product definition and system architecture design, ensuring compliance with IVD standards and collaborating across various teams to enhance product offerings.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Systems EngineeringRequirements EngineeringRisk ManagementVerification/ValidationFDA StandardsISO StandardsTechnical Problem SolvingCollaboration SkillsOrganizational Skills

Required

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
Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master's with 2 years, or PhD)
Demonstrated knowledge in systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA
Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards
Interest in innovative technologies and understanding of the IVD competitive landscape

Preferred

Deep knowledge in reliability, manufacturability, and usability
Proven ability to build authority and accountability within a team, with strong collaboration and communication skills
Excellent organizational skills, capable of evaluating, prioritizing, and managing multiple projects efficiently

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase