R&D Program Manager Role
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1. Manage new medical device development to meet patient, customer and business needs.
2. Serve as Project Lead on one or more projects, developing plans and goals aligned with overall company objectives.
3. Develop project plans, timelines, budget and resource requirements for stakeholders.
4. Translate project plans and goals into work package ownership areas for team members and align with management team members on individual goals and work package ownership.
5. Support team members in executing work and delivering project deliverables as the product advances through design development cycle.
6. Communicate with stakeholders across the company and externally to develop project/product inputs, set and manage expectations, and provide updates on project progress, risks and issues.
7. Implement robust engineering practices and processes in product design and development to ensure final product reliability and quality.
8. Prepare regulatory submission-ready documentation for FDA and other regulatory bodies.
9. Support clinical activities including limited clinical case support. Investigate root cause of identified product failure modes.
10. Counsel and mentor senior engineers without direct supervisory authority.
11. This role may take supervisory/management responsibility of a small number of junior engineers or technicians.
Qualifications:
1. Bachelor's degree in Mechanical or Biomedical Engineering, or related field.
2. Seven years in similar role in medical device product development, with minimum three years in project management/leadership role of technical projects across R&D and Manufacturing.
3. Project management skills - capable of operating at all levels including managerial, project and technical.
4. Deep understanding of FDA and ISO 13485 requirements.
5. Experience in design, verification, and process validation processes.
6. Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.
7. Excellent communication, organisational and time management skills.
8. Good problem-solving mindset.
9. Strong verbal and written communication skills.
10. Effective in start-up environment and able to deliver in low-structured environments.
11. Demonstrated ability to communicate within team/company structure and achieve project and company objectives.