This role in Endo Vascular will focus on all aspects of the product life-cycle and will develop, document, and manage a comprehensive product development program to meet all internal and external requirements. The scope of this position will include contributing to and defining the design and development strategy, and overall planning and execution of the product’s development, preparing and reviewing documentation, partnering with component product suppliers, working with functional engineering teams to create detailed designs, and supporting products through their life-cycle activities for existing products. This role will provide leadership to a small technical team with capability in the areas of electronic hardware/software, guidewires, and device development and packaging, while functioning as the R&D lead.
- To take ownership of all R&D activities developing project requirements, plans, and schedules for the development and approval of the device/system, and agree with the Senior leadership team.
- To Lead concept assessment and product development via customer input, DRM, and knowledge of technical feasibility.
- Interact with customers, clinicians, and business stakeholders to document clinical/market needs and competitive landscape.
- To conceive, communicate and refine by collective involvement with clinicians, company management and other healthcare stakeholders, the optimum product development pathway
- Work on the roadmap for device development and advancement for the platform Technology in Vascular Access and in Vascular Intervention.
- Develop and manage the requirements definition process for new products (e.g. customer requirements, product specifications, system specifications, etc.), in conjunction with the senior management team.
- Ensure and maintain, safety, efficacy, quality and overall compliance in the process development of the product technology with patient safety and medical device regulatory requirements.
- Manage all stages of product development workflows. Promote organizational objectives to team members including engineers and/or technicians, ensuring readiness for on time and within budget close out of development milestones and phase reviews.
- Provide leadership and guidance for the solution of non-routine problems requiring substantial judgment and independent evaluation, selection, and adaptation of standard engineering techniques, procedures, and criteria.
- Work with vendors and internal departments to obtain necessary resources, resolve inter-departmental issues and contribute toward organizational objectives.
- Provide input to annual budgets and is accountable for managing to that budget.
- Conduct project/team meetings as required to resolve issues, determine current status, provide information, and assign work. Ensure adequate communication between engineers, technicians, and other departments.
- Provide reports and presentations to management as required.
- Provide written documentation regarding unusual problems and solutions.
- Manage the selection, compensation, appraisal, feedback, training, and development processes within the team to ensure optimum attraction, motivation, and retention of employees, in conjunction with the senior management team.
Required Skills, Experience, and Competencies
- A Degree in Engineering or appropriate technical discipline, and a minimum of 10 years of technical work experience, with five to seven years of project and people management experience.
- A dynamic team player and leader who can work effectively and proactively on cross-functional teams, while having the strength and understanding to work outside defined functional boundaries when required.
- Comprehensive working knowledge of development and qualification of single-use disposable medical devices such as guidewires catheters stents and atherectomy devices.
- Excellent written, verbal and interpersonal communication skills, the ability to influence all levels of management.
- The ability to train, teach and lead others, and the ability to improve situations with proactive problem-solving skills and solution-oriented negotiation skills.
- Executes: Takes accountability for and delivers consistent decisions, actions, and results. Aligns team, allowing people to move quickly in a coordinated fashion
- Clear Thinking: Translates complexity into simplicity and articulates crisply and clearly, Creates and communicates a clear strategy/plan, Demonstrates good judgment
- Driven To Win: Passionate and driven, Makes tough decisions in difficult situations, Capacity for work
- Inspires Others: Authentic and sets a vision that inspires performance and engages others, infectious enthusiasm, Seeks and values different perspectives and ideas to foster an inclusive work environment
- Boundaryless: Breaks down silos, collaborates across organizational boundaries, Fosters diverse thinking and integration
- Compliance & Integrity: Promotes and practices a culture of integrity, ethics, and compliance with laws and policies. Champions implementation of compliance policies, training, and monitoring programs. Expeditiously takes appropriate actions when problems occur