Principal Mechanical R&D Engineer (Systems)
Senior Mechanical R&D Engineer (Systems) will be responsible for developing disposable and non-disposable medical 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.
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.
- Experience with Catheter design and development a plus.
- Comprehensive knowledge of 3-D CAD, including drafting standards and GD&T.
- Intermediate experience with MS Excel, Word, and Project.
- Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products.
- Demonstrated experience in managing internal and external development resources to achieve product development goals.
- 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.
- Previous experience in ensuring a smooth transition to manufacturing.
- Strong work ethics with a team-oriented mindset.
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.