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Posted: Monday, January 8, 2018 4:51 PM

Senior Project Engineer at Invuity

Position Description:

The Senior Project Engineer will lead complex medical device design, development, transfer and scale-up projects as part of a cross-functional team, to achieve targets in a timely fashion and to meet agreed upon quality standards. This role requires strong hand's-on technical/mechanical engineering skills alongside project management, influential and innovation skills, and a thorough understanding of design controls, change and risk management principles and regulatory requirements for medical devices. There will be extensive collaboration with internal partners and this person must build and maintain strong relationships with key internal partner organizations including but not limited to: R&D, Engineering, Quality Assurance, Regulatory, Procurement, Ops teams. The Senior Project Engineer will report to the Director of Program & Project Management and will be located at our headquarters in San Francisco. This is a regular, exempt, full-time position.

Essential Duties and Responsibilities:

* Lead cross-functional project teams who are responsible for the management and execution of medical device development projects.

* Ability to articulate complex mechanical designs from concept to product realization using Solidworks.

* Be knowledgeable in developing/reviewing tooling specifications for fabrication of molded parts.

* Proactively provide expert scientific and technical guidance and leadership/mentorship to engineers and technicians to enable them to optimally meet their development project objectives.

* Develop project schedules, cross-functional deliverables and detailed timelines, as well as identify and manage project priorities and project dependencies.

* Provide project leadership in the concept, feasibility, development, qualification and launch phases of device development:

* Assist with identification of user needs, usability and human factors engineering, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight.

* Identify and communicate business and technical risks for project in timely manner.

* Lead project meetings, track progress in meeting minutes, keep team focused and manage action items for stake holders.

* Aid in interface with Supply Chain partners to ensure timeliness of deliverables.


* Strong understanding of Design Controls and assembly of Design History File (DHF) components.

* Fluent in working under the requirements of ISO 13485 and FDA device regulatory requirements in order to be strategic in planning, program progress oversight/execution, communication, and process management.

* Facility with:

* Solidworks

* MS Project

* MS Office Suite

* BS or MS in Engineering, Optics or Material Science field, preferably Mechanical Engineering, or Biomedical Engineering with ME emphasis.

Nice to Haves:

* Experience in optomechanical and/or surgical instrumentation design and development.

* Tech File content and assembly for CE submission.

* Previous experience with optics/optical engineering.


Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain


• Location: San Francisco

• Post ID: 93213482 sf is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018