- Company Name
- Hyper Recruitment Solutions
- Job Title
- Software Engineer
- Job Description
-
**Job title**: Software Engineer
**Role Summary**: Design, develop, and maintain high‑quality software for pharmaceutical and medical device products, ensuring regulatory compliance and supporting full product lifecycle in an Agile environment.
**Expectations**: Deliver robust solutions that meet stringent quality and safety standards; collaborate cross‑functionally with engineering, product, regulatory, and clinical teams; lead technical discussions and continuous improvement initiatives.
**Key Responsibilities**:
- Architect, code, debug, and document software for new and existing products, using object‑oriented languages (C#, C++, or similar).
- Participate in Agile/Scrum ceremonies, create build pipelines, automate tests, and enhance infrastructure.
- Work with Test Engineering, Product Management, Design Assurance, Regulatory Affairs, and Clinical teams to capture requirements, define specifications, and ensure traceability.
- Identify, analyze, and resolve software defects, performance bottlenecks, and reliability issues.
- Maintain regulatory compliance documentation and support audits of software artifacts.
**Required Skills**:
- Strong programming in C#, C++, or equivalent.
- Proficiency with version control (Git, Perforce, Azure DevOps, SVN).
- Deep understanding of OS, data structures, algorithms, multithreading, and software architecture.
- Debugging, troubleshooting, and analytical problem‑solving abilities.
- Experience with Agile/Scrum, CI/CD, automated testing, and infrastructure automation.
- Excellent communication and collaboration skills across multidisciplinary teams.
**Required Education & Certifications**:
- Bachelor’s degree or higher in Computer Science, Software Engineering, or related field (or equivalent experience).
- Knowledge of regulatory standards applicable to life‑sciences software (e.g., 21 CFR Part 820, ISO 13485) is desirable.