Responsibilities

• 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.

Minimum requirements/qualifications:

These are the only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee, such as performance level, capable contribution level, and company need.

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

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.