Sr. Mechanical R&D Engineer
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Senior Mechanical R&D Engineer will be responsible for the mechanical development of a high-voltage nanosecond pulsed electric field generator. Responsibilities include: taking concepts from early prototypes to volume production, working closely with users 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 injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.
- Ensure a smooth transition of new products into manufacturing.
- Manage projects with cross-functional teams following design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc.
- Exhibit a great attitude 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 mechanical design expertise with medical devices, preferably designing surgical generators or similar capital equipment.
- Proven track record of generating innovative concepts that can be turned into manufacturable products.
- Fundamental understanding of mechanical engineering theory including: heat transfer, strength of materials, materials, sheet metal and enclosure fabrication, chassis design, capital equipment manufacturing techniques.
- Understanding of electronics and circuits.
- Previous experience in ensuring a smooth transition to manufacturing.
- 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 3-D 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 experience in medical device industry required. Startup experience a plus.
Pulse Biosciences, Inc. is a development-stage medical device company using a novel and proprietary platform technology called Nano-Pulse Signaling or NPS. NPS can be tuned to induce a variety of cellular responses including secretion, apoptosis and necrosis by modulating the NPS pulse parameters, making it applicable to a wide variety of cell types and therapeutic applications. One of the more promising applications of NPS is the treatment of solid tumors, where pre-clinical data has shown that NPS provides effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic apoptosis of the cells.