Sr. Mechanical R&D Engineer (Catheter)
Senior Mechanical R&D Engineer will be responsible for developing catheter-based devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: taking concepts from early prototypes to volume production, working closely with physicians/cath lab personnel to obtain design feedback in a clinical environment, and developing close ties with new vendors. You will play a critical role in an early-stage startup environment with a small R&D team.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Design and develop high-volume medical devices that can be manufactured via extruding, braiding, laminating, bonding, injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, etc.
- Quickly prototype and test concepts for feasibility. Analyze data for efficacy.
- Ensure a smooth transition of new products into manufacturing.
- Manage projects with cross-functional teams following design control processes while generating catheter-based requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc.
- Exhibit a great attitude and flexibility as a team player who excels in a demanding start-up environment.
- Understand the company’s quality policy and quality system requirements applicable to tasks.
- Comply with company policies/procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Extensive intravascular catheter design and test experience with extrusions, braided shafts, balloons, insulation, articulating/steerable designs, varied French sizes, heat/tip forming, bonding, etc.
- Broad experience with catheter materials - polymers, adhesives, epoxies, coatings, etc. Experience with nitinol is a plus.
- Intimate knowledge of international standards for catheter design (i.e. EN ISO 10555)
- Proven track record of generating innovative catheter-based concepts that can be turned into manufacturable products.
- Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques.
- Previous experience in ensuring a smooth transition to manufacturing.
- Previous experience with energy-based delivery systems is a plus.
- Strong work ethics with a team-oriented mindset.
- Demonstrated experience in managing internal and external development resources to achieve product development goals.
- Demonstrated problem-solving skills.
- Comprehensive knowledge of SolidWorks CAD including drafting standards and GD&T.
- Excellent verbal and writing skills. Experience with MS Excel, Word, and Project.
EDUCATION and/or EXPERIENCE:
BS or MS in mechanical engineering required. Five years of relevant catheter experience in medical device industry required. Startup experience a plus.
Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano-Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.
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All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.