- 47201 Lakeview Blvd, Fremont, CA 94538, USA
THINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical systems for orthopedic surgery. The systems include two components: a 3D workstation for preoperative planning, and a computer assisted tool utilized for cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide
Job Summary: The Project Manager works directly with both engineering and clinical stakeholders to structure key requirements into solutions for surgical robotic devices and applications. You will be responsible for the management and organization of project teams to ensure requirements, designs and project objectives are met within expected timelines and budget. This role is instrumental in helping define an overall PMO structure and providing guidance and support to the project management team.
Travel Requirements: This position may require less than 10% travel.
- Plans, coordinates, and drives completion of medical device applications for robotic systems.
- Collaborate with clinical and engineering groups to develop solutions and overall strategies that address complex high and low level requirements.
- Leverages strong engineering background to participate in system and software design and development activities.
- Oversees the procedural compliance aspects of the development lifecycle effort by interfacing with quality and regulatory personnel.
- Collaborate cross functionally to capture and document requirements, support risk assessment, ensure development of test and validation plans, manage resources to realize product development milestones, complete design transfer activities, and support product releases.
- Maintains design history file and all supporting documentation through the project lifecycle.
- Builds and maintains good working relationships with team members, vendors, and consultants. Coordinates activities between groups to ensure efficient project execution. Reports on progress to management.
- Lead discussions between the development and clinical teams to capture user requirements, stories, use cases, business flows and acceptance criteria.
- Leadership role to ensure that project management structure is optimized across the organization to standardize approach and drive efficiency.
- Provide cross functional coordination for projects that require use of internal and external suppliers for operations execution.
- A Bachelor’s degree in engineering and 3+ years of experience in medical devices as a project manager.
- Expertise in project management for medical devices.
- Strong communication skills for collaborating with cross-functional teams.
- Strong knowledge in medical device development.
- Hands-on engineering, proven ability to lead a team.
- Experienced with all phases of the product development life cycle including design, implementation, debug, verification, qualification, design transfer, and maintenance.
- Experience with manufacturing and prototyping.
- Knowledge and experience with Microsoft Windows and Office Products, including Visio and Project.
- Knowledge of good manufacturing practices (GMP) and applicable FDA and CE Quality System Standards.
- Experience/background in orthopedics.
- Thorough knowledge of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD) requirements, IEC 62304 Medical Device Software – Software Lifecycle Processes, General Principles of Software Validation – FDA Guidance, and IEC 62366 Medical Devices – Application of Usability.
- Thorough understanding of:
- FDA medical device regulations, guidance, and import/exports requirements.
- Medical device labeling and promotional requirements
- Medical device quality systems
- Product development processes
THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow’s leading orthopedic solutions today, we would love to hear from you.
THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.