What are the responsibilities and job description for the Device Engineer position at Transpire Bio?
Job Specific Information
Summary
An individual with extensive ( >
10 years ) engineering depth and breadth in both technical and supplier / project management. The technical expertise should be automation process development and validation and device design verification (see below for details). This background enables the individual to be deployed to a wide array of Device Engineering needs with little direction and little to moderate support.
Essential Duties and Responsibilities
Project / Supplier Management Skills :
Device Engineering at Transpire Bio primarily drives development (product design, manufacturing, supply chain) via leveraged external teams. To make a contribution in this environment, the Device Engineer must be comfortable collaborating with global teams on distributed projects (e.g. CMO in US, prototyping in Asia, design in Europe, pharmaceutical in Weston). This role has excellent communication and information management skills.
Technical Expertise :
In addition to project management skills, this role has considerable technical proficiency in Mechanical Engineering. Preferred specializations include Automation, Process Development, and ideally Validation. The individual is able to quickly come up to speed on a wide variety of technical matters associated with the Device and also at the interface between the Device and Pharmaceutical. This includes manufacture (design) transfer, design verification and validation, and ultimately registration of the device. He / she is also able to quickly comprehend external partner technical issues and anticipate the impact to Device and Project.
Specific examples – typically work with external partners like CMO, consultants and test labs.
- Design (manufacturing) transfer : process development, testing, qualification, document generation and change control.
- Design verification : plan testing based on device nature and specs (including generate and update device specs).
The device engineer makes tactical project decisions with Device Engineering Director informed and consults (or receives direction from) Device Engineering Director for any higher-impact strategic decisions.
Qualification Requirements
