Senior Project Manager

THINK Surgical, Inc.•Fremont, CA

2h•Onsite

About The Position

The Senior Project Manager is accountable for leading and driving projects and matrixed cross-functional teams for new product development and sustaining engineering projects to drive the scoping, planning, prioritization, resource management, and execution of established design controls process across THINK Surgical’s product portfolio spanning orthopedic robotic surgical systems, tools and accessories. This position is instrumental in delivering business results supporting new product development, commercial and manufacturing goals under a medical device quality management system and providing tactical leadership, guidance, and support to the R&D organization. This position is based in THINK’s corporate office.

Requirements

Bachelor’s degree in a technical field e.g. engineering, life sciences, computer science and 5-8 years of industry experience, either in medical device product development, manufacturing or sustaining engineering projects.
Knowledge and experience in the application of project management principles.
Strong communication skills for leading, influencing and collaborating within cross-functional teams and across management stakeholders.
Experience in leading cross-functional teams through all phases of the product development life cycle including scoping, design, debug, verification, validation, qualification, design transfer, and implementation.
Proficiency in Microsoft Windows and Office Products, including scheduling software applications such as Project or Smartsheet, and team collaboration tools such as Microsoft Teams, SharePoint, Atlassian, Confluence, or equivalent applications.
Thorough knowledge of Good Documentation Practices and Design Controls.
Thorough understanding of: FDA medical device regulations Medical device labeling and packaging/shipping Medical device quality systems Product development processes
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality Management System Standards.

Nice To Haves

Experience in facilitating assessments and tradeoffs among desired product features, customer/user needs and requirements, business value, technical feasibility, resources/costs and time to market.
Ability to quickly and effectively consolidate and integrate information into plans and timelines, setting clear goals and driving execution towards milestones, goals and KPIs achievement.
Proficiency in and use of Atlassian applications: Jira, Confluence, resource planning tools
Certification in project management, e.g. PMP or equivalent certification or training.
Additional experience in relevant FDA medical device regulations, guidance, medical device labeling, and Design History File (DHF) management. Experience in establishing and maintaining DHFs, organizing and tracking project deliverables within a DHF using an electronic document management system.
Self-motivated, hands-on, can zoom in and out of topics easily and without distraction, is decisive when the situation calls for it, has the capacity to be flexible and open to new ideas with the ability to adapt to change in an emotionally intelligent and professional manner.
Works effectively in a fast-paced and dynamic environment where attention to detail, managing ambiguity and competing priorities is needed while operating with a high level of professionalism, initiative and follow through.

Responsibilities

Be accountable for project/program management planning and execution of assigned projects.
Collaborate with technical and business/commercial leaders to establish early phase project charters, scope and project plans in alignment with product portfolio roadmaps and organizational goals and priorities. Incorporate business and commercial strategy, technical capabilities, budget and resources in early phase project assessments.
Collaborate with cross-functional core teams to develop integrated project plans that identify work breakdown structures, durations, dependencies, resource assignments within budgetary guidelines.
Understand interdependencies between technology, operations, and business/strategic needs and apply knowledge to balance tradeoffs in planning and managing project risks.
Set project goals and milestones to drive meaningful progress while balancing project risk.
Establish and maintain good professional working relationships with internal and external project and organizational interfaces, e.g. coworkers, management, suppliers, consultants, and development partners.
Coordinate activities between different functional teams to ensure efficient project execution.
Present and report project status regularly at program and product business reviews to management stakeholders.
Actively manage and work collaboratively across functions to deliver project milestones, goals and associated KPIs according to THINK Surgical’s established quality management system and applicable medical device regulations and standards.
Oversee the procedural compliance aspects of the product development lifecycle by interfacing with quality and regulatory personnel.
Lead and facilitate core team meetings, fostering an environment for effective lines of communication and engagement on project and technical risk management, clearing roadblocks and guiding teams towards aligned decisions and strategies.
Work with relevant team members and functions, drive the completion of business and design history file deliverables, design, technical and project reviews and phase closure reviews.
Leverage engineering/technical expertise in electrical/mechanical, hardware/firmware/software to gather impact of design updates/changes to requirements, determine system, subsystem and component-level testing and verification/validation strategies, establish project plans and methods of tracking and reporting status of project activities, deliverables, project risks and risk mitigation proposals.
Collaborate and coordinate with engineering disciplines, manufacturing/supply chain, quality, and regulatory functions and external suppliers and partners to develop solutions and overall strategies that address commercial, product quality/reliability and manufacturing/supply chain goals.
Ensure project management activities are assessed for process improvements and optimized across the Sustaining Engineering and Program Management organizations to standardize approach and drive efficiency.
Apply knowledge and experience in project management best practices, PMO frameworks, tools and templates enabling teams to achieve consistency and reliability in project execution.