Responsibilities
1. Process Improvement & Governance
2. Assess current R&D NPD processes and identify opportunities for efficiency, quality, and compliance improvements.
3. Define and implement best-in-class systems engineering practices tailored to biotechnology product development.
4. Establish clear process interfaces across functions (R&D, Quality, Regulatory, Operations, Marketing).
5. Systems Engineering & Design
6. Develop frameworks and templates for requirements management, system design planning, product concepts, and integration strategies.
7. Ensure effective traceability across requirements, design, verification, and validation.
8. Guide teams in applying systems thinking to complex biotech product architectures.
9. Documentation & Standards
10. Create, update, and maintain standard document templates:
11. User & system requirements
12. System integration design planning
13. Product concept & feasibility documentation
14. Risk analysis, verification, and validation plans
15. Promote consistent documentation practices to improve knowledge transfer and regulatory readiness.
16. Cross-Functional Collaboration
17. Partner with R&D scientists, engineers, program managers, and regulatory experts to embed system integration principles in daily work.
18. Provide coaching, training, and mentoring on best practices in requirements, design, and integration documentation.
19. Continuous Improvement & Innovation
20. Benchmark industry standards and introduce digital tools (., PLM, requirements management systems) to streamline documentation and design workflows.
21. Act as a thought partner in shaping the future of R&D operations, enabling scalability and faster time-to-market.
Qualifications
Education:
22. Bachelor’s or master’s in systems engineering, Biotechnology, Biomedical Engineering, or related technical discipline.
Experience:
23. 10+ years of experience in R&D systems integration, product design, or process excellence within biotech, medical devices, or life sciences.
24. Proven track record improving NPD processes and creating standardized templates for requirements and integration documentation.
25. Strong knowledge of systems engineering methodologies (., INCOSE, V-model) and regulatory frameworks (., FDA, ISO 13485).
Skills:
26. Expertise in requirements management, integration planning, and design control.Strong documentation and technical writing ability.Familiarity with PLM systems, requirements management tools, and digital collaboration platforms.Excellent facilitation and change management skills to align cross-functional teams.