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Director of Engineering/Product Development

2 months ago

Broomfield, United States Aspero Medical Full time

Company Description

Aspero Medical, located in Broomfield, CO, is a young, preprofitable, medical device company with its first product in commercial distribution and accelerating the development and subsequent product launches of our sterile, single use, Ancora product line.  These products are specialty endoscopy overtubes that facilitate current and new, less invasive procedures in gastroenterology that will help physicians improve interventional care. Ancora products represent a $1.5B global market opportunity in the growing field of advanced, 3rd space endoscopy. Aspero's novel, patented technology maximizes frictional properties, enhancing mucosal wall traction and anchoring consistency in the gastrointestinal tract without injury. Founded in 2018, Aspero is investor and grant funded.


Role Description

This is a full-time on-site role for a (non-executive) Director of Engineering/Product Development that works directly with senior management to lead (and directly participate in) engineering development of new and improved company products. Investigates and evaluates product strategy, product architecture, product design (as individual contributor) while managing and collaborating with internal staff and outsourced resources to ensure products meet the clinical, technical, functional and regulatory requirements on time and within budget. Within a small engineering team, pursues assigned projects and engineering efforts derived from corporate objectives. Oversees and coordinates, with Senior Management, the larger team effort related to project planning, product development, manufacturing process development, risk management, and supplier management. Works in compliance with the company’s Quality Management System (QMS). Direct management of development staff. We are a very small team looking for a candidate that is hands-on in the details, focused, goal oriented, self motivated, personable, a good communicator and can work simultaneously as both a strong individual engineering contributor and manager.


Qualifications

  • Strong engineering management and team leadership skills
  • Strong design and development skills
  • Expertise in sterile disposable medical device development and project management
  • Proven track record of successfully delivering complex projects to the market
  • Excellent problem-solving and decision-making abilities
  • Experience championing quality in the V&V process, ensuring appropriate verification and validation is successfully completed against a comprehensive listing of product requirements and engineering specifications.
  • Experience with product development under ISO 14971 (risk management).
  • Proficient with Solidworks CAD and exhibits advanced computer skills, current user
  • Bachelor's or Master's degree in engineering or related field
  • Minimum 5 years of experience in technical and department leadership of medical device product development.
  • Minimum 15 years of experience with FDA or ISO regulated quality systems
  • PMI or related certification is a plus.


Compensation

Commensurate with experience, education and skills. Aspero offers an attractive package of salary, bonus potential, equity, 401(k) participation, and benefits. This position is a director level role, non-executive.