Senior Project Manager

Fremont, CA, United States

Job Summary

The Senior Project Manager is accountable for leading and driving projects and matrixed cross-functional teams in the scoping, planning, resourcing, and execution of all phases of product development from concept to commercial launch of advancements of current products and next generation robotic surgical systems, cloud-based digital health platforms and surgical planning software applications. This position is based in the Fremont, CA office or the Sacramento, CA office.

Duties & 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 and scope in alignment with product portfolio roadmaps, product release planning and feature assessments. 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. Set project goals and milestones to drive meaningful progress while balancing project risk.

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.

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.

Coordinate with vendors and suppliers as needed.

As the primary contact for project teams, executive and senior leadership stakeholders, provide and maintain project dashboards for reporting on project status, accomplishments, risks and mitigation and escalation. Regularly present and communicate project dashboards, project health, milestones, and critical path to targeted audiences in the project environment.

Understand interdependencies between technology, operations, and business/strategic needs and apply knowledge to balance tradeoffs in planning and managing project risks.

Assess internal processes and process documentation to identify and implement improvements that drive efficiency and value within PMO and across the organization. Apply knowledge and experience in project management best practices, PMO frameworks, tools and templates enabling teams to achieve consistency and reliability in project execution.

Supervisory Responsibilities

N/A

Qualifications

Required:

Bachelor’s degree in a technical field e.g. engineering, life sciences, computer science and 5-8 years of industry experience, preferably in medical device product development.

Strong communication skills for leading, influencing and collaborating within cross-functional teams and across management stakeholders.

Experienced with structured phase gate processes for the product development life cycle including scoping, design, implementation, debug, verification, validation, design transfer, and maintenance.

Knowledge and experience with Microsoft Windows-based applications, such as Microsoft Teams and Office 365 product suite, Project management applications such as Smartsheet, Microsoft Project or equivalent applications.

Knowledge of Good Manufacturing Practices (GMP) and one or more applicable Quality System

Standards, e.g. ISO 13485, FDA Quality System Regulations Medical Device per 21 CFR 820, EU MDR.

Preferred

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.

Practical experience in medical device software development life cycle processes, cybersecurity planning and controls, development, testing, validation, implementation, and release.

Proficiency in and use of Atlassian applications: Jira, Confluence

Prior training, certification and/or experience in Agile methodologies e.g. Sprint Planning, Scrum, Kanban

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.

COMPETENCIES

Project Planning, Execution and Risk Management methodologies

Skilled in oral and written communications

Prepares and delivers concise and meaningful presentations

Collaborates effectively at all levels

Leads with confidence and enthusiasm

Operates with a problem-solving and continuous improvement mindset

Takes initiative and accountability for actions and results

PHYSICAL DEMANDS & WORK ENVIRONMENT

Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.

Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.

Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.

Occasionally work around moving mechanical parts.

Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.

Must be able to travel as business necessitates (up to 10%).

Disclaimer

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. (“THINK”) is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with his/her employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States.

Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.

THINK Surgical, Inc. also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States.

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