Project Manager, Sustaining Engineering jobs in United States
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THINK Surgical · 1 month ago

Project Manager, Sustaining Engineering

positionFremont, CA, US
timeFull-time
remoteOnsite
seniorityMid Level
money$120K/yr - $135K/yr
date3+ years exp

THINK Surgical is a company focused on robotic medical devices. The Project Manager, Sustaining Engineering will manage and execute sustaining engineering projects, ensuring they meet objectives within timelines and budgets while collaborating with various functional teams.

BiotechnologyHealth CareMedicalRobotics
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H1B Sponsor Likelynote

Responsibilities

Plan, coordinate resources and activities, and drive the completion of multiple sustaining engineering projects involving hardware and/or firmware/software design changes and updates
Collaborate with engineering, manufacturing/supply chain, quality, and regulatory functions to develop solutions and overall strategies that address commercial, product quality/reliability and manufacturing/supply chain goals
Leverage engineering expertise and background 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
Oversee the procedural compliance aspects of the product development lifecycle by interfacing with quality and regulatory personnel
Collaborate cross functionally to manage matrixed resources to realize project milestones, complete design transfer activities, and support design change implementation/inventory management and release schedules
Create and maintain DMR/DHR/DHF records and files and all supporting documentation through the project lifecycle
Build and maintain good professional working relationships with team members, vendors, and consultants
Coordinate activities between different functional teams to ensure efficient project execution
Report on progress to management at weekly and monthly program reviews
Ensure project management activities are optimized across the Sustaining Engineering and Program Management organizations to standardize approach and drive efficiency
Provide cross functional coordination for projects that require use of internal and external suppliers for operations execution

Qualification

Medical device experienceProcess improvementFDA regulationsProject management principlesMicrosoft Office proficiencyQuality System StandardsOrganizational savvyEffective communicationTime management

Required

Bachelor's degree in an Engineering discipline and 3+ years of experience in medical device project management or manufacturing operations
Knowledge and execution of project management principles
Strong knowledge in medical device and/or manufacturing field
Hands-on process improvement experience and success
Strong communication skills for collaborating with cross-functional teams
Experience in leading cross-functional teams through all phases of the product development life cycle including design, verification, qualification, design transfer, and implementation
Knowledge and experience with Microsoft Windows and Office Products, including Project or Smartsheet
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

Preferred

Prior experience/background driving projects and initiatives within a manufacturing or sustaining engineering environment
Thorough knowledge of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and Medical Device Directives (MDD) requirements
Thorough understanding of FDA medical device regulations
Medical device labeling and packaging/shipping
Medical device quality systems
Product development processes

Company

THINK Surgical

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THINK Surgical is a medical device company that develops, manufactures and markets active robotic surgical systems for orthopedic surgery.
dateFounded in 2007
location
Fremont, California, USA
people-size51-200 employees
web-link
http://thinksurgical.com

H1B Sponsorship

THINK Surgical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (9)
2022 (9)
2021 (5)
2020 (7)

Funding

Current Stage
Growth Stage
Total Funding
$244.21M
Key Investors
David C. DvorakKDB Investment
2023-06-28Undisclosed· $5M
2022-10-26Private Equity· $100M
2022-04-07Undisclosed· $5M

Leadership Team

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Aditya Bhowmick
Senior Software Engineer, TPLAN
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Recent News

PR Newswire
THINK Surgical appoints Josh DeRienzis as Chief Legal Officer
2025-11-07
EIN Presswire
Demand for Personalized Knee Implants Market is forecasted to reach a value of US $3.2 billion by 2029
2025-08-22
PRLog
Surgical Robots Market: What Stakeholders Need to Know
2025-08-13
Company data provided by crunchbase