Principal R&D Engineer : Bioresorbable Scaffold For ...

Principal R&D EngineerClass III Bioresorbable Scaffold : PAD InterventionProduct Design / Development : V&V / Design TransferHybrid Bay Area : Full Time Direct HireOur client is a rapidly growing Bay Area leader in the vascular intervention arena developing a novel 1st of its kind class III sirolimus coating bioresorbable scaffold aimed to improve the standard of treatment for below-the-knee (BTK) peripheral arterial disease (PAD).This new stent platform is uniquely designed with an ultra-high molecular weight polylactic acid polymer to balance strength and flexibility as a well-needed advancement over traditional metal drug-eluting stents.This new PAD stent innovation will be a much-welcomed alternative to below-the-knee amputation and could be a highly disruptive concept in a $2.5B+ US PAD market.Current critical need is toward a new Principal R&D Engineer position responsible for developing and supporting new and existing technologies, products, equipment, and processes. The position plays a critical role in technical leadership and directly contributes to development and manufacturing of innovative vascular solutions through the product lifecycle.Our client has just recently raised a substantial tranche of new financing to fund company-wide organizational expansion ensuring this new Principal R&D Engineer is well-resourced to complete their mission.Responsibilities:Product & Process DevelopmentDevelop concepts and prototypes for new and existing products and manufacturing processes.Actively participate or lead user needs assessment process through interacting with KOLs, clinicians, and Clinical Affairs and Operations staff.Create product, assembly, and parts specification, CAD models, and drawings.Manage parts suppliers or contract manufacturers to create parts that meet specification.Leadership and ManagementProvide technical leadership to company teams. Provide training and mentorship to engineers and technicians. Educate Operations and Clinical Affairs teams on technical details and proper function/use of tools and devices.Organize and execute development and improvement projects.Develop and maintain comprehensive clinical and technical product knowledge. Recognize and understand competitive products including industry trends.Product & Process Validation and VerificationValidate and verify device and parts designs and manufacturing processes through methodical scientific tests.Write test protocols, conduct tests, and write test reports to document validation and verification activities.Actively participate or lead risk assessment reviews and phase reviews for new and existing devices and processes.Assist in resolving complaints in a prompt and effective manner to include proper device or process complaint investigations.Participate in device performance evaluation through pre-clinical & clinical tests.Manufacturing Knowledge Transfer and TrainingDocument manufacturing and testing processes for Operations to ensure consistent process output.Assist in managing and training Operation staff on executing manufacturing and testing instructions.Monitor manufacturing process output, root cause issues, and create solutions to increase process success.Administrative ResponsibilitiesSupport clinical by providing technical details for devices and procedures and participating in planning and monitoring clinical cases.Participate in managing device production and inventory including device shipments, usage and return of product.CommunicationMaintains a high level of communication with cross functional team members and leadership.Qualifications:Educational RequirementsBachelor's degree in engineering Excellent interpersonal and written communication skills.ExperienceMinimum of 5 years of medical device development and manufacturing.Experience in medical device development. Knowledge of regulated medical device industry and clinical environment.Demonstrated understanding of anatomy, physiology, and pathway to care.Stent/ Catheter/ Peripheral Vascular intervention experience is preferred.IDE/PMA/regulatory experience with catheter, stent, drug delivery device.Firm grasp of scientific and engineering concepts associated with materials, mechanics, heat transfer, flow dynamics, mechatronics, software UI either through undergraduate/graduate program or on-the-job training.Hands on concept-to-prototype and tech transfer to manufacturing experience.Hands on packaging/sterilization, V&V protocol/testing/reporting experience.Hands on CAD/CAM/FEA, traditional machining, and rapid prototyping experience.High degree of familiarity with preclinical and clinical operations.Experience in managing prototyping/manufacturing schedule and staff.

Created: 2025-02-19