- Title: Device Engineer
- Code: RCI-10020044
- Location: South San Francisco California (CA) 94080
- Posted Date: 03/27/2020
- Duration: 12 Months
- Name:Shailesh Sargara
- Email: Shailesh.Sargara@rangam.com
- Phone: 908-704-8843 ✖ 219
The Device Development department is searching for a dynamic Device Engineer to bring innovative drug delivery devices into clinical and commercial production to support next-generation drug pipeline. The candidate is expected to have technical expertise in the development of drug-device combination medical products, and be able to provide technical leadership to support engineering, scientific, and manufacturing activities. The candidate will be assigned to teams developing leading-edge mechanical drug delivery devices while meeting the highest standards of quality and reliability.
The candidate will be responsible for providing design, development, and commercial support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics. The candidate, working with senior engineers and scientists, will work independently with general direction from project teams or functional management. The work is reviewed upon completion.
Job responsibilities may include –
Device Engineering development
- Primary: Design and develop dproducts that provide the most cost effective, robust and reliable performance for medical devices
- Characterize device designs and important material attributes (MAs) using appropriate tools such as DOE, tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
- Identify design input requirements, ensure compliance with standards and SOP’s and support development of control system/design transfer.
- Procure lab-scale testing equipment. Design, fabricate, and procure fixtures for device evaluation
- Review change requests associated with design of the product.
Design Controls, risk management, and cGMP for biologics, pharmaceuticals, and medical devices.
- Primary: Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Proven experience in providing engineering technical input to a team composed of internal members along with external development partners and component suppliers is required. The ability to interact at a detailed technical level with process, human factors, and industrial engineers is also an essential skill. In depth experience with design controls, test method development, and design verification methodologies is also required.
Required Qualifications and Skills –
- Advanced degree, B.S., or M.S., in engineering or related discipline, with preference for Mechanical Engineering, or the equivalent.
- Experience collaborating with internal and external suppliers and providing technical support to internal cross functional teams
- Self-Starter with excellent problem solving skills
- Prior experience with Design Controls
- Drafting of device design verification protocols/reports and conducting design verification testing.
- Strong Technical expertise in mechanics/selection of materials,
- General CAD experience (Solidworks preferred – not a primary responsibility)