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Systems Engineer
2 hours ago
Seeking a Systems Engineer to drive software 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 SW product definition, requirements, risk analysis, and testing.
--Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation.
--Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software 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 software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation.
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 software 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.
Pay ranges between $40-45/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
