Software Systems Engineer I - Diagnostics & IVD
Planet Pharma
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Job summary
Planet Pharma seeks an Associate Systems Engineer - Software to drive software product definition, requirements, risk analysis, and verification/validation to meet IVD standards. This role supports cancer diagnostics through advanced testing automation and global instrument deployment.
The ideal candidate has a Bachelor's degree in Engineering, Biomedical Sciences, or related field with 0-2 years' experience, strong systems thinking, and familiarity with FDA/ISO regulatory environments.
Qualifications
- 0-2 years of engineering experience in a regulated diagnostics environment.
- Knowledge of software integration, requirements, risk, and testing lifecycle.
- Familiar with FDA/ISO standards for diagnostic products.
- Strong analytical and problem-solving skills with cross-functional collaboration.
Responsibilities
- Apply Systems Engineering to SW product definition and requirements.
- Manage software requirements, risk analysis, configuration, defects, and V&V.
- Research industry trends and competitive software features.
- Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams.
- Engage with business leaders and Voice of Customer to align solutions.
- Analyze complex technical challenges and present informed decisions.
Skills
Education
Job description
Planet Pharma seeks an Associate Systems Engineer - Software to drive software product definition, requirements, risk analysis, and verification/validation to meet IVD standards. This role supports cancer diagnostics through advanced testing automation and global instrument deployment.
The ideal candidate has a Bachelor's degree in Engineering, Biomedical Sciences, or related field with 0-2 years' experience, strong systems thinking, and familiarity with FDA/ISO regulatory environments.
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