Responsible to: CEO
Purpose of Job (Summary)
Summary of Role:
The R&D Engineering Manager is responsible for driving innovations and projects critical to business strategies and objectives. Through direct leadership and mentorship of others, the R&D Engineering Manager sets technical direction in the development of new products & solutions dedicated to breast & body aesthetic transformation (reconstruction or augmentation).
The R&D Engineering Manager applies broad-based technical expertise gained through hands-on experience in product development and product support to solve complex technical problems, and exercises considerable discretion and latitude in developing and executing work plans.
- Contribute, lead and provide guidance on critical initiatives on behalf of R&D as required to support business needs.
- Develop a product strategy road map and execute it when approved
- Effectively recruit, develop, organize, and motivate a staff of skilled associates.
- Provides technical leadership working directly with other functional groups
- Demonstrate strong and clear accountability for the group’s development, performance, and results.
- Accountable for improving and further developing processes and best practices.
- Authors and/or reviews project sub-plans, reviews requirements, risk management results, protocols, reports, architecture, and configuration management deliverables. Assigns resources to and/or participates in CAPA investigations.
- Ensure regular updates are provided to the leadership team on key initiatives within the portfolio.
- Accountable for the successful execution of key initiatives within the portfolio (e.g. portfolio rationalization (PASO methodology))
- Align dedicated resources cross-functionally to optimize and ensure execution success.
- Ensure product development process are followed through right execution and technical rigor.
- Ensure adequate support to Customer, sales, manufacturing; marketing and service.
- Support development & maintenance of detailed budgets in accordance with project, department, and business objectives.
- Ensure efficient and effective transition of product development programs to high volume manufacturing in locations throughout the GCA organization
- Identify, assess, and develop state-of-the-art organizational capability in:
- Project leadership, execution and communication.
- Technology, product development, continuous improvement & change control.
- Six Sigma (DFSS) gate reviews for New Product Development & Sustaining Engineering projects (optional)
- Productivity metrics to constantly measure performance.
- Critical parameters management
- Test method development, Product validation and verification
- Maximizing throughput, effectiveness and efficiency.
- Accountable for leading and organizing functional reviews as required.
- Active engagement in detailed review of cross-functional plans and be accountable for their success.
- Perform periodic reviews of progress against plans. Ensure plans are executed appropriately within department. Be accountable for timely delivery of all development deliverables as specified.
- Ensure compliance with GCA and applicable local, state and federal quality policies, procedures, practices and regulations.
- Hold a degree qualification (PhD/Master’s minimum) in either one or more of the following disciplines: Mechanical Engineering, Electrical Engineering, Design Engineering, and/or Bioengineering, or a Life Sciences (Chemistry or Biology) discipline.
- Experience in a combination of medical device and product development (Class II or III medical device appreciated)
- Have 5 or more years’ experience within the medical device industry and experience of managing, coaching and leading multiple and complex product development and new process projects involving direct and multi-disciplinary teams both internally and externally (surgeons, clinicians, researchers, suppliers etc.) accumulating in a proven track record of bringing new medical device products to the market is essential.
- Strong technical judgment and extensive technical leadership skills.
- Demonstrated capability of leading R&D product development projects and sustaining engineering teams.
- R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases.
- Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Experience in directing associates and leading small cross-functional groups is required.
- Disciplined phase-gate product development processes & project planning.
- Strong creative, analytical and problem-solving skills required.
- Good written & verbal communication skills (fluent in English, French and/or Spanish basic if possible)