Project Manager, Sustaining Engineering

THINK Surgical, Inc.•Fremont, CA

33d•Onsite

About The Position

The Project Manager, Sustaining Engineering works directly and cross-functionally with R&D Sustaining Engineering, other R&D Engineering and Manufacturing/Supply Chain functional teams and stakeholders to drive the planning, prioritization and execution of sustaining engineering projects and design changes for THINK Surgical’s robotic medical devices and accessory products. You will be responsible for managing, planning and tracking the execution of Sustaining Engineering projects through established design control and change control processes to ensure project objectives are met within established priorities, timelines, budget and resources. This role is instrumental in delivering business results supporting commercial and manufacturing targets under a medical device quality management system and providing leadership, guidance, and support to the Sustaining Engineering function. This position will report to the Program Management Office (PMO) with dotted line reporting to the Sustaining Engineering function. This position is based in the Fremont, CA office.

Requirements

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.

Nice To Haves

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

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.