Device Engineer I/II

BEPC has an open position for a Device Engineer I/II Location: South San Francisco, CA Requisition ID: ROCGJP00020903 Benefits: Medical, Dental, Vision and Life Insurance Pay Rate: $50 – 57/hr. Description: The Device Development department is searching for a dynamic Device Engineer to bring innovative drug delivery devices into clinical and commercial production to support the company’s next-generation drug pipeline. The candidate is expected to have technical expertise in the development of medical device and/or drug-device combination 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. Job Responsibilities: The candidate will be responsible for providing design, development, and commercialization 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 · Procure, design and develop lab-scale test equipment and test methods. · Design, fabricate, and procure fixtures & methods for device evaluation (primarily optical or tensile based methods) · Develop designs that provide the most cost effective, robust and reliable performance for medical devices · Characterize device designs using appropriate tools such as DOEs, components of variance, house of quality, etc. · Characterize important material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, FEA, etc. · Conduct Design Verification · Review change requests associated with design of the product. · Design Controls, risk management, and cGMP for biologics, pharmaceuticals, and medical devices. · Understand, implement and maintain Pharma Quality Policy and Pharma Quality System (PQS) in the department. · Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices. · Assist with resolving issues due to internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions. · Create and review discrepancy, change and risk management documents for devices teams. · Ensure compliance of training to PQS and job-related requirements. · Participate in hazards analyses, design assessments, and design reviews. Education: Proven experience in providing engineering technical input to a team composed of internal members along with external development partners and component suppliers is required. Medical Device/Combination Product experience is necessary. 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 (in order of importance) – · Advanced degree, B.S., or M.S., in engineering or related discipline, with preference for Mechanical Engineering, or the equivalent. · 3 years of experience in industry or academia (including advanced studies) after receiving their Bachelor’s Degree. · Experience collaborating with internal and external suppliers and providing technical support to internal cross functional teams · Prior experience with Design Controls · Proven experience in test method validation and Gage R&R · Drafting of device design verification protocols/reports and conducting design verification testing. · Expertise in CAD (Solidworks preferred), Rapid prototypting, material selection/biocompatibility, DFX, etc. · Experience statistical analysis and interpretation of data. · Familiarity with risk management tools (developments of pFMEAs, etc.). · Highly organized, detail oriented and strong communication skills including technical report reviewing and writing. Job Type: Contract Pay: $50.00 - $57.00 per hour Benefits: Dental insurance Health insurance Life insurance Vision insurance Schedule: 8 hour shift Work Location: In person