Planet Pharma · 4 hours ago
Systems Engineer - Integration
Tucson, AZ
Contract
Onsite
Mid Level
$42/hr - $45/hr
4+ years expPlanet Pharma is seeking a Systems Engineer to join their R&D team. The role involves driving requirements definition, risk management, and verification & validation practices, while collaborating with cross-functional teams to ensure project deliverables meet IVD standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
System Lifecycle Management: Apply broad knowledge and skill-sets from Systems Engineering, focusing on the requirements engineering, risk management, and verification & validation stages of the system lifecycle
Industry and Technology Analysis: Research and analyze industry trends, emerging technologies, and competitive products to identify opportunities for robust requirements, proactive risk mitigation, and effective validation strategies
Cross-functional Collaboration: Work closely with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with organizational objectives and regulatory requirements, particularly regarding traceability, risk, and validation
Customer-Focused Innovation: Engage with business leaders and VoC representatives to ensure technical solutions align with customer needs and market demands, facilitating stakeholder discussions to prioritize requirements, assess associated risks, and define appropriate validation criteria
Technical Problem Solving: Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address requirements definition, risk mitigation, and verification & validation challenges
Project Execution: Execute project deliverables specific to requirements engineering, risk analysis, configuration management, defect management, and verification & validation in the company-specific tool
Qualification
Required
Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master's degree with 2 years of experience, or a PhD)
Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation
Experience working in a regulated environment, with familiarity with FDA, ISO, and other relevant regulatory standards for diagnostics products, especially regarding requirements, risk, and validation
Demonstrated interest in innovative technologies and understanding of the competitive landscape in IVD, with an eye for potential risks, critical requirements, and robust validation approaches
Preferred
Deep knowledge in requirements elicitation, risk analysis methodologies (e.g., FMEA), usability engineering, and V&V test strategy development
Proven ability to build authority and accountability within a team, with strong collaboration and communication skills, particularly in facilitating discussions around complex requirements, risks, and validation plans
Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities; capability to formulate and solve problems, and complete work in a timely, accurate, and thorough manner, especially in managing extensive requirement sets, risk registers, and verification & validation matrices
Familiarity with the assay development process and its associated requirements, risks, and validation needs
Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart
Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry, to better define requirements, assess risks, and plan validation across system components
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
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 StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase