Principal Mechanical R&D Engineer (Disposable Device)
Principal Mechanical R&D Engineer will be responsible for leading the developent of disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: coming up with new concepts then taking the 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:
- Leading the design and development of high-volume medical devices which can be manufactured via, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.(desired)
- Ensure a smooth transition of new products into manufacturing.
- Manage projects with cross-functional teams following FDA design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc.
- Exhibit a healthy attitude as a team player or leader who excels in a fast-paced start-up environment.
- Understand the company’s quality policies and quality system requirements as applicable to tasks.
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 abilities required.
- Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
- Demonstrated experience in managing internal and external development resources and design projects through the complete development cycle from concept through full commercial launch of new medical products following the FDA required design control processes.
- Strong documentation and project skills required.
- Experience with Catheter design and development a plus.
- Comprehensive knowledge of 3-D CAD Solidworks, including drafting standards and GD&T.
- Intermediate level experience utilizing MS Excel, Word, and Project.
- Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products.
- Fundamental understanding of mechanical engineering theory including: mechanisms, injection molding (required), strength of materials, materials, adhesives, and high-volume manufacturing techniques. Understanding of electronics and circuits a plus.
- Previous experience in ensuring a smooth transition to manufacturing.
- Strong work ethics with a team-oriented mindset.
EDUCATION and/or EXPERIENCE:
- BS/MS in mechanical engineering required. Ten years of relevant experience with the medical device industry required. Startup experience desired.