About:
The role involves overseeing the R&D and Engineering functions in support of product design and development, process engineering, sustaining engineering and product validation, and assists Operations with production.
Responsibilities:
- Lead the development of new products and manage the design changes in existing products.
- Build and manage the R&D / Engineering (CAD, Testing, Simulation…) capability to support new product development and sustaining engineering activities.
- Develop the strategy and lead the implementation for optimizing the product design including the related manufacturing processes.
- Work closely with the clinical team and end-users to monitor the performance of the products in the field during clinical studies and post-market surveillance to understand if any design changes are required.
- Work closely with the COO to validate the assembly, packaging and sterilization processes.
- Provide program management support across the organization where it is needed, including but not limited to: Finalizing the manufacturing and sterilization processes and developing market entry plans for each relevant country.
Experience & Qualifications:
- Requires a Master’s Degree in Mechanical Engineering / Design / Physical Sciences with at least 10 years of experience leading Design and Development functions in the medical technology industry
- Direct experience in developing medical devices following the V&V processes, from Customer Requirements to Design validation, involving DOE, DFSS, DFM techniques.
- Experience in driving external suppliers & experts (in the various fields of: testing, manufacturing, sterilization, microbiology, toxicology…) in the objective of developing and supporting medical devices.
- Experience of managing / contributing to DHF, DHR and DMR.
- Experience of representing R&D / Engineering function in the Quality Management Reviews and during internal and/or external audits.
- Strong exposure to Project Management activities, with experience of leading cross-functional and international teams from different culture, location and time zone.
- Ability to strategize the engineering activities and outcomes in alignment with quality and business goals for organisation.
- Must be able to collaborate effectively with Quality, Regulatory, Operations, Marketing, Clinical/Medical Affairs, and other functional areas.
- Ability to solve problems, and to perform root cause analysis.
- Coach and mentor R&D employees as they are hired, and ensure all employees are trained on the Quality Policy.
- Strong interpersonal skills with excellent ability to communicate orally and in writing to cross functional teams, and ability to travel internationally for working with partners from different culture and domain of expertise.
- Passionate about the purpose and embraces the values of inclusivity, teamwork, and personal responsibility.
