UNLOCKING LIFE THROUGH MOBILITY
The Opportunity
Director of Research & Development
Aliso Viejo, CA-
Video - A message from David Lalor, VP of Operations/R&D
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Overview
Vertos Medical is moving into its newest stage of growth and innovation. The new VP of R&D is looking for a talented Director of R&D to join his team and focus on stage 2, 3, and 4 of the product development lifecycle with a focus on product design and development up to technology transfer and launch. The right leader will get to grow and mentor a team, drive and coordinate cross-functional partnerships, and ensure team understanding and accountability to project investments, schedules, and hitting timelines. The VP has an empowerment, servant-leader mentality and needs a partner who can lead and that is hungry to grow.
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Responsibilities
Assume complete responsibility of projects to ensure on-time, on
budget, per plan delivery of quality products including development,
product verification, and validation testing. The leadership includes
overall design, requirement development, design for manufacturing,
and test methods.- Leads design and development with strong hands-on experience in mechanical design development
- Strong influence on proof of concept and manufacturing, DOM, and technology transfer best practices
- Develop, manage, and maintain up-to-date project timelines
inclusive of all critical milestones, key interdependencies and
resource constraints, while applying appropriate project scheduling techniques. - Guide project team activities to meet project and business objectives including approval of project recommendations through governance; drive team accountability for deliverables and ensure projects meet milestones.
- Lead cross-functional team.
- Create Design History file that complies with FDA and ISO medical
device requirements. - Define scope and ensure stakeholder alignment, resource, and risk
management, project leadership, team development and
communication. - Proactively identify and escalate risks and issues to relevant
stakeholders; lead development and delivery of tactical and
achievable mitigation and contingency planning.
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Qualifications
- BS in Mechanical Engineering, Biomedical Engineering, Aerospace Engineering, or relevant degree/Advanced Degrees are preferred
- 10+ years’ relevant experience with at least 3 in mechanical design development.
- Experience leading teams with a minimum of 3 years of leadership experience with direct reports.
- Must be a strong leader and mentor with a servant leadership mentality.
- Must be hungry for growth and ready to make an impact in a growth environment.
- Experience in managing Class II device development programs in the medical device space with knowledge of regulatory and quality requirements.
- Strong understanding of quality systems, regulatory requirements, development, and manufacturing processes.
- Strong experience in mechanical design development, proof of concept, product launches and know the pitfalls to avoid.
- Strong, proactive leadership style with a proven track record of hitting timelines and following schedules.