**JOB SUMMARY**:
The position strives to achieve the successful implementation of strategic/transformational programs related to the Costa Rica Site, leading and leveraging processes, technologies, capabilities, and people.
The position will have its reporting line to the Dir Pharm Tech in close coordination and collaboration with all functional departments.
**KEY DUTIES AND RESPONSIBILITIES**:
**Duties and Responsibilities % of Time**
- Manage and coordinate various stakeholders and disciplines to ensure support and successful execution of the assigned transformational Program(s).
- Implement appropriate governance, monitor progress, manage risks/challenges and if required, drive escalation.
- Coordinate and execute with HR an appropriate Change Management strategy.
10% - Define & align the scope, requirements, deployment, timeline, budget, and implementation plan for the assigned transformational Program(s).
- Plan and control the Costa Rica Site program(s) budget while working closely with Finance to ensure spend is in line with expectations.
15%
- Establish & lead cross-functional workstreams within the assigned Program(s) with strong emphasis on facilities, equipment, assembly and inspection methods, training, SAP readiness, supply of raw materials and components.
15% - Lead, manage and motivate the program(s) team to achieve the defined Program(s) objectives.
10% - Proactively anticipate and remove bottlenecks, while timely communicating risks and issues to stakeholders.
10% - Prepare applicable program(s) documentation per the requirements of the Quality System.
- Lead/execute the specific program(s) activities assigned to the Pharm Tech role.
40%
**JOB QUALIFICATIONS (MINIMUM REQUIREMENTS)**:
- The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job._
**Education and Experience**
- Bachelor's degree in Engineering or equivalent.
- Minimum 7 years of engineering work experience, preferably in a medical device development and manufacturing environment.
- Comprehensive project management experience with track record of several successfully completed cross-functional, strategic projects.
- Sound knowledge and proven practical experience in project and investment/cost controlling.
- Strong leadership with ability to lead & facilitate cross functional teams in a matrix environment and demonstrated collaboration skills.
- Strong ability to recognize and mitigate both technical and organizational challenges.
- Excellent communication and presentation skills (both verbal and written) in English.
- Strong ability to manage complexity and to work on several parallel workstreams.
**Knowledge**
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory and safety compliance requirements and guidelines.
- Design Control Process (ISO 13485 and FDA QSR 820).
- Device manufacturing process design/DFM and scale-up including equipment, testing, assembly operations and support systems.
- Assembly processes and equipment/fixturing (semi-automation, full automation).