**About the position**:
**Responsibilities**
- Lead a dedicated group of engineers and technicians within the Project or Manufacturing Group.
- Ensure engineers are fully integrated within the overall project and production support team.
- Plan and implement training and development plans with subordinates.
- Complete design and development projects through training and guidance of technicians.
- Coach and mentor of team members.
- Establish engineering goals and objectives that deliver results according to the business plan. Identify and establish permanent and effective technical/systems solutions to problems.
- Consistently meet customer requirements and commitment to performance excellence and meet deadlines.
- Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
- Defend compliance with Creganna Medical's systems and processes.
- Identify and develop improvements to increase key metrics of the Service, Delivery, Quality and Cost process using Lean/6 sigma methodologies.
- Research state-of-the-art process technologies and evaluate the potential competitive advantage and cost benefit of the introduction.
- Lead or guide projects in conjunction with other resource management (i.e., NPI, quality engineering, design assurance, R&D, and other cross-functional departments) related to engineering. Work with the team to plan, coordinate and implement activities to support the successful launch of new products, including buy/purchase analysis, introduction of new processes and others. Develop/modify manufacturing processes by studying product requirements; research, design, modify and test manufacturing methods and equipment.
- Maintain professional and technical knowledge by attending educational workshops; review of professional publications; personal networking; participating in professional societies.
- Manage external relationships with key technology providers.
- Manage a variable workload to meet operational requirements.
- Ensure that all health, safety and environmental requirements are met.
- Oversee and drive validation activities, including equipment IQ/OQ, process OQ/PQ, process characterization, validation of attribute/variable testing methods and associated documentation.
- In-depth knowledge related to the links between the Master Validation Plan, pFMEA, dFMEA, risk management.
**Education & Experience**
- Bachelor's degree in an Engineering field or equivalent, with 5-10 years of experience in a demanding high-volume production environment.
- Knowledge of medical devices or systems of similar quality and manufacturing is a must.
- Experienced CAD tool user, preferred SOLIDWORKS experience.
- A proven ability to lead a production/technical troubleshooting-focused team with a proven track record of line configuration including equipment procurement and process development
- Working knowledge of sigma and/or lean engineering principles with a proven track record in using and delivering results.
- Statistical knowledge, including data analysis and the use of statistical software (JMP, Minitab, etc.).
- Lean Six Sigma: Green Belt Certification Preferred
- Must be fluent in English, both written and verbal, more than 80%
**Competencies**:
- Values: Integrity, Accountability, Teamwork, Innovation
