R&D Engineer - Mechanical

Insurgical is an Austin, TX based medical device company focused on developing innovative, single-use reprocessed surgical power equipment for the medical industry.  We are continuing to add talent in Austin as part of our aggressive growth strategy.  We need innovative A-players that work well with little supervision and thrive on the ability to jump into a high-impact role on day-1.  For the right individual, this position offers the ability to grow to higher levels as the company continues its exciting path forward. 

As a Mechanical Engineer in R&D, you will be responsible for developing and commercializing future products for the company, expanding upon our existing portfolio of devices used in procedures every day.  You will develop, modify and finalize CAD (SolidWorks) drawings and models for new components, build and test prototypes, complete quality and regulatory documentation, communicate with key vendors and ultimately be responsible for commercializing exciting new products.  You should have an intense curiosity and a desire to climb steep learning curves quickly.

Key Responsibilities

• Modify CAD files and verify form, fit and function.
  • Utilize tolerance stackups and understand interferences before prototyping
• Create CAD files for new accessories as defined by Marketing
  • Own product development from concept to commercial release
• Interface with vendors, both domestic and international
• Interface with contract manufacturers
• Document design and BOM drawings and details
• Write Engineering Protocols and Reports for Validation and Verification product testing
• Define incoming quality inspection processes for key components
• Support documentation and filing requirements for CE and FDA regulatory requirements for medical products
• Design and participate in manufacturing and testing processes
• Contribute across multiple departments

Requirements

• 3+ years of Mechanical Engineering experience
• 1+ years of Project/Product/Program/Process Management experience
• 1+ years of experience with new product development
• Advanced SolidWorks modeling/drafting capabilities
• Ability to work effectively, creatively, and efficiently with minimal management and oversight
• Strong desire to work with small, high-growth, entrepreneurial organization
• BSME or Electrical/Chemical/Biomedical/Manufacturing Engineer with additional experience

Prefer

• Medical Device knowledge, including regulatory and Quality systems
  • Or sufficient exposure via previous projects, schooling, or internships
  • General understanding of Anatomy and interest in surgical procedures.
• Experience with machined, molded, or cast metal parts
• Experience with plastic injection molding process and tooling
• Experience with electromechanical products