Job title : Senior Mechanical Engineer
Job Number :
Division : Engineering
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 innovative 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.
• 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 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.
• Engineering: 4 years