Senior Project Manager

3. Experience

• Seven years of working experience in a highly regulated industry.
• Experience with Design Control, Quality Management Systems, internal/external audits, CAPA, Change Control, Complaint handling, Transfer from R&D to Production, Post Market Surveillance, supplier quality.
• Experience in resource planning and management. Knowledge of project management methods and estimation techniques.
• Experience with outsourcing and negotiation with 3rd parties.

4. Skills

• Excellent communication skills, both orally and in writing
• An energetic and driven professional with organizational talent and ready to take responsibility.
• Flexible, proactive, and a team player.
• Able to create a great working atmosphere.
• Quality-conscious, results-oriented, and business-minded.
• Negotiation skills
• Works well in a fast-paced environment
• Process & Results oriented
• Self-starter

5. Nice to Have

• Working knowledge of process improvement skills, including Six Sigma, Lean Sigma, Knowledge Management, and Process Design.
• Experience in utilization methods such as design of experiments, risk management, validation, verification, systematic problem solving, and statistical analysis.
• Experience with root cause investigation methodologies.

2. Education: Bachelor's Degree in engineering, science or technical field or equivalent, Master's Degree preferred.

• Formulates the overall project plan (including timing, budget and necessary staffing plans) in consultation with management and other parties.
• Is responsible for implementation and realization according to the project plan (specification, quality, time, money, information, and organization). Manages project progress and takes necessary corrective actions.
• Directs employees within the project and gives them operational guidance, both technically and organizationally.
• Manages external development partners and/or subcontractors where applicable. Executes projects under his/her responsibility pragmatically and in line with company processes and applicable regulations for medical devices in our target markets.
• Provides management board with regular project performance status, including identified risks and mitigation scenarios of the project with regard to specifications, costs, planning, etc.
• Reports on employees’ performance to line managers and other resource owners for the purpose of performance appraisal and makes proposals for further competence development.