Sr. Mechanical R&D Engineer
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Senior Mechanical R&D Engineer will be responsible for developing percutaneous and laparoscopic surgical devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: taking concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical 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 laparoscopic or percutaneous disposable and reusable medical devices.
- Proven track record of generating minimally-invasive 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. Understanding of electronics and circuits a plus.
- 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 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.
Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.