Principal R&D Engineer
Class III Bioresorbable Scaffold : PAD Intervention
Product Design / Development : V&V / Design Transfer
Hybrid Bay Area : Full Time Direct Hire
Our 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 Development
- Develop 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 Management
- Provide 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 Verification
- Validate 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 Training
- Document 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 Responsibilities
- Support 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.
Communication
- Maintains a high level of communication with cross functional team members and leadership.
Qualifications:
Educational Requirements
- Bachelor’s degree in engineering or relevant education.
- Excellent interpersonal and written communication skills.
Experience
- Minimum 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.
