POSITION SUMMARY:
The Sr/Staff Process Development Engineer will be a core team member of the Product Development group leading early development of novel manufacturing processes. Additionally, the engineer will oversee, troubleshoot, and improve existing production processes. This role will focus on our novel catheter product line.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES

• Design and prototype novel manufacturing processes.
• Identify areas of improvements in current processes, create and execute and improvement plan.
• Create and execute DOEs to determine critical parameters.
• Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
• Represent Manufacturing on cross functional teams ensuring proper DFM.
• Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure Good Manufacturing Practices (GMP).
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic.
• Actively work to promote team building and morale within the department.

  REQUIRED QUALIFICATIONS

• Minimum 5 years of related experience in the medical device industry in a manufacturing or R&D role.
• Cardiovascular Catheter assembly using processes such as adhesive bonding, thermal bonding, and ultrasonic welding.
• Proven track record using a variety of design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate the value of new concepts.
• Ability to exercise sound decision-making and good judgment consistent with a senior level position.
• An inventive aptitude balanced with discipline and detail-orientation.
• A willingness to work hard, with a driven outlook and with a strong desire to succeed as both an individual and as a key part of a team.
• Proficiency in Solidworks or Onshape and MS Office suites.
• Proficient with statistical analysis software is a plus.
• Languages: Full professional proficiency in English.