Principal R&D Engineer : Bioresorbable Scaffold For Peripheral Arterial Disease : Hybrid Bay Area

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.