Senior R&D Project Manager

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AquaBeam® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size, or surgeon experience.

SUMMARY
This role within the R&D group is responsible for growing and overseeing PROCEPT BioRobotics’ project management activities. The position manages projects adhering to PROCEPT BioRobotics’ internal design controls while working cross-functionally advancing development, prototypes, testing, documentation, and production transfer as well as management of external development and manufacturing resources. The position works closely with, and in compliance to, PROCEPT BioRobotics’ quality management system (QMS) and applicable global regulations. The Senior Project Manager provides leadership to engineering core team in the development and implementation of new solutions for current and future product lines and manages support from various inter-departmental contributors.

CORE RESPONSIBILITIES (Other duties may be required as assigned)

• Project Management – Actively helps manage R&D projects through on-boarding, executing, monitoring and reporting on projects including adherence to the schedules and milestones; supports the growth of new Project Managers; advances the tools and processes utilized by the project management team. Sets, manages, and reports on project budgets within departmental budgets.
• Resource management – Instrumental team member for resource management, identifying and assigning resources across all projects.
• Sustaining Engineering – Management of development and improvements of the existing generation of the Aquablation System and related accessories.
• Cross-functional leadership – Drives collaboration between multidisciplinary stakeholders and subject matter experts; leads projects requiring inputs and deliverables from adjunct department contributors.
• Risk Management – Solicits inputs from development team and stakeholders on project and product risks; anticipates, captures, and dispositions risk through the project risk registry or RAID (risks, assumptions, issues, and dependencies) log; contributes to risk management activities and documentation.
• Requirements – Collaborates with clinical, quality, regulatory and marketing to develop product specifications.
• Reporting – Responsible for regular project reporting and communications down to the development team and up to stakeholders; manages the program dashboard by regularly updating progress, milestones, risks, scope and deliverables; collaborates with other project managers and department leadership on regular reporting to the Executive Steering Committee.
• Development planning – Responsible for generating and maintaining the project schedule, monitoring progress, and directing resources; works with stakeholders, Product Owner/Manager and development team on Agile and Phase Gate development planning; manages Agile product backlog, daily scrums, reviews and retrospectives; manages phase gate development processes; designs Agile sprints, epics and stories along with Phase Gate development plans in accordance to PROCEPT BioRobotics’ design controls procedures.
• Quality/regulatory – Owns the responsibility for Design History File (DHF) and Device Master Record (DMR), supporting compliance to the QMS and regulations, leading design reviews, managing controlled documentation and supporting audits; leads documentation management and release in support of domestic and international regulatory approvals; assists in any technical trouble shooting associated with complaint processing, CAPA resolution and execution.
• Supply chain – Develops and maintains relationships with established and new suppliers - domestic and international; sets up projects with fabrication contractors for components or assemblies; ensures suppliers have adequate quality systems, good manufacturing practices, manufacturing process control and that they can meet requirements for regulatory compliance and produce products to quality standards.
• Verification and validation – Plans and coordinates testing to assess feasibility of new products, trouble shoot existing issues and verify requirements; works cross-functionally on the development of protocols, builds, procurement, testing, reporting and documentation release.
• Quality Management System – Maintains trained status for, and complies with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• Quality Policy – Understands and adheres to the PROCEPT BioRobotics Quality Policy.
• Environmental Health and Safety (EHS) Policy - Understands and adheres to the PROCEPT BioRobotics EHS Policy.

QUALIFICATIONS (Education, Experience, Certifications)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BS or MS degree in Electrical or Mechanical Engineering required
• 5+ years’ experience in R&D project management related to the development of medical electronic devices comprising a combination of mechanical, electronic, integrated circuit, software and embedded system design
• Experience working in a structured design process such as ISO 13485 or FDA QSR, knowledge of regulatory approval process and requirements
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public.
• Ability to work as part of a multi-disciplinary team in a small, fast-paced company
• Ability to balance hands-on detailed design tasks and project management/planning functions
• Strong written and oral communication skills
• Strong interpersonal skills. Needs to have the ability to manage and influence vendor engineering teams outside of the office.

Physical demands
The employee is occasionally required to attend animal or cadaver labs and to manipulate models and/or organs for testing
The employee frequently packs and unpacks packages
The employee may occasionally lift and/or move up to up to 50 pounds
The employee may occasionally need to travel domestically and internationally to meet with users, evaluate clinical product use, support trade shows or manage suppliers.

Work environment
While performing the duties of this job, the employee regularly works in an office environment.
The employee will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
The employee will occasionally be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn.
While performing the duties of this job, the employee occasionally exposed to a warehouse environment.

The above statements are intended to describe the general nature and level of work being performed.
They are not intended to be construed as an exhaustive list of all responsibilities.

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