R&D Manager, Agile SW Champion

JOB DESCRIPTION:

Responsible for activities related to the technical support and process/product development engineering functions for current and next-generation products. Plan and implements the development of new processes, develop, and coordinate new product development projects, and provide technical leadership and supervision to engineers and technicians. Ensures that program objectives are determined and met, logistics are effectively coordinated, and budgets are adhered to.

Core Job Responsibilities:

• R&D Manager of Product Development within the site working on Physiology and OCT Imaging solutions treating coronary artery disease.
• Lead a Process team that has responsibility for Requirements, Agile Scrum Process, SW Development Procedures, and Dev Ops.
  • Responsible for coaching the SW Development team to stay true to best practices of a scaled agile framework applied to Med Device.
  • Coach team of engineers to generate and refine requirements starting from user needs to design inputs to sub-system software and hardware requirements.
  • Cross-functional collaboration to ensure SW Development quality procedures stay compliant with regulatory standards while maintaining business efficiency.
  • Support the site with the administration of key software development tools (Dev Ops).
• Influence the site toward continually improving our product development process to improve business efficiency and capitalize on time to market.
  • The exciting niche of the company’s product portfolio: Optimizing treatment of percutaneous coronary intervention (PCI) procedures
  • Healthy 5+ year product pipeline of software, hardware, and sustaining projects
• Coaching the organization in SAFe adoption
• Helping Agile mindset transformation within the organization
• Removing barriers between stakeholders and Agile Teams
• Coaching the team members in self-management and cross-functionality
• Helping the Agile Team focus on creating high-value Increments that meet the Definition of Done
• Causing the removal of impediments to the Scrum Team’s progress
• Ensuring that all SAFe Agile Team events take place and are positive, productive
• Helping find techniques for effective Product Goal definition and Product Backlog management
• Helping the Scrum Team understand the need for clear and concise Product Backlog items
• Helping establish empirical product planning for a complex environment
• Facilitating stakeholder collaboration as requested or needed
• Direct supervision of 4-person team composed of Scrum Masters + Requirement Engineers
• Recruits, coaches, and develops organizational talent.

• Develops direct reports securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate, and conducting formal written and verbal reviews.
• Provides technical direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May supervise non-exempt employees.
• Interacts with internal and external customers, by meeting regularly, responding to requests,s and explaining procedures.
• Monitors compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.), is considered an expert in their area, and partakes in internal and external auditing activities.
• Contributes to the development and monitoring of area budget through regular analysis of the department’s annual budget.
• Keeps the organization’s vision and values at the forefront of decision-making and action.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
• Provides leadership to assigned staff by communicating and providing guidance towards achieving department objectives.
• Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.
• Assignments are expressed in the form of objectives and tasks; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
• Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with the substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.
• Flexible to some remote work
• Minimal travel required

Required Qualifications:

• R&D Manager in Med Device
• Previous Agile (SAFe) Champion
• Engineering degree (MS preferred): Biomedical, Computer Science, Mechanical, Electrical
• Experience using Atlassian product suite (JIRA)
• Experience generating requirements and managing requirements of the capital systems in the Med Device industry
• Strong communication & presentation skills
• Clinically savvy in the current med device field
• Understanding of Customer User Needs
• General Clinical Understanding
• JIRA experience
• Managerial Experience in a Medical Devices setting, Required
• General Clinical Understanding
• Understanding of Customer User Needs

Preferred:

• Experience using the JAMA Requirement management tool
• Background in writing or oversight
• Human Factors Experience