Director, R&D Product Sustainment Engineering
Position Overview
Create, lead, and oversee the R&D Product/Sustaining Engineering organization and related projects, including, but not limited, market expansion projects, post-launch R&D support, and R&D system and process improvements. Requires strong leadership, exceptional organizational and project management skills, and a deep understanding of the management and execution to ensure successful project delivery across the organization. Job duties:Leadership and Strategy
- Develop and execute a comprehensive R&D Product/Sustain Engineering strategy for the medical device division, aligned with the organization's goals and objectives.
- Provide strategic guidance and direction to the team, ensuring efficient resource allocation and effective project delivery.
- Foster a culture of collaboration, accountability, knowledge sharing and continuous improvement.
- Oversee the planning, execution, and monitoring of R&D Product/ Sustaining Engineering projects listed in the Description Summary.
- Manage project timelines, risks, issues, and dependencies, implementing proactive measures to mitigate potential obstacles.
- Establish project management best practices, tools, and methodologies to enhance project outcomes and efficiency.
- Conduct regular reviews of projects to identify risks, issues, and dependencies, and implement mitigation strategies.
- Collaborate closely with cross-functional teams, including R&D, regulatory affairs, manufacturing, quality assurance, and marketing, to drive project success.
- Facilitate effective communication and collaboration between internal and external stakeholders, ensuring alignment and shared objectives.
- Provide regular updates on project status, milestones, and risks to senior leadership and key stakeholders.
- Partner with HR to attract, recruit, coach, develop, and manage talent to support associates career development and to ensure a strong succession plan is in place.
- Lead the resource planning and allocation process, ensuring that project teams have the necessary skills and capacity to deliver projects effectively.
- Optimize resource utilization across multiple projects, balancing priorities and addressing conflicts.
- Identify opportunities for resource development and training to enhance the capabilities of the project management team.
- Drive a culture of continuous improvement, implementing feedback mechanisms, lessons learned, and process enhancements.
- Stay current with industry trends, regulations, and best practices in medical device project management, and apply them to improve project delivery.
- Implement project performance metrics and dashboards to track progress, identify areas for improvement, and report on key performance indicators.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Bachelor's degree in a relevant field of study (e.g., engineering, business, life sciences, etc.).
- Minimum of twelve (12) years of relevant professional experience in project management within the medical device industry.
- Minimum of five (5) years of high-level leadership experience.
- Demonstrated track-records in development products and delivering them to the market successfully.
- Strong working knowledge and experience in a regulated industry such as medical device or pharmaceutical or similar.
- Proven track record of successfully managing complex projects and delivering results on time and within budget.
- Exceptional leadership, written and verbal communication, and stakeholder management skills.
- Proficiency in project management software and tools and MS Office Suite, including Word, Excel, Outlook, and Teams.
- Advanced degree in a relevant field of study (e.g., engineering, business, life sciences, etc.).
- Project Management Professional (PMP) certification highly desirable.
- Strong knowledge of medical device development processes, regulatory requirements, and quality management systems.
- Excellent analytical skills to produce accurate data and solution proposal.
- Use of computer-assisted engineering, design software, and equipment to perform engineering and design tasks.
- Excellent computer software and coding skills.