Associate Engineer

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 for gastroenterology specialties. 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, 3^rd space endoscopy. Aspero's novel, patented technology maximizes mucosal "grip without injury," enhancing mucosal wall traction for advancing devices and anchoring stabilization in the gastrointestinal tract . Founded in 2018 as a spinout of the University of Colorado, Boulder, Aspero is investor and grant funded.

Role Description

Reporting to the Director of Product Development, this position supports the development and evaluation of new and improved single use devices in a small, collaborative team structure with considerable hands-on efforts in our lab/facility. The successful candidate pursues assigned tasks within a larger team effort that encompasses product development, product evaluation, manufacturing process development, test development, equipment development, and supplier qualification. Works in compliance with the company’s Quality Management System (QMS).

Responsibilities

• Supports product development by executing project tasks, as requested by management and senior engineering staff.
• Works with other members of the engineering staff to ensure project milestones are met with tasks fully completed and on time.
• Follows reliable, efficient, and cost-effective procedures.
• Work is generally collaborative in nature.
• Works from schematics, engineering drawings, and written or verbal instructions.
• Supports creation of supportive documentation, including test protocols, test reports, proposed component specifications, etc.
• As requested, supports the procurement of materials, components, and services (fabrication, testing, calibration, preventive maintenance, etc.)
• Supports hands-on efforts of fabricating prototypes and test samples.
• Collaborates to ensure the correct design aspects are being tested and evaluated.
• Operates testing equipment/fixtures, conducts test, and analyzes data in a prescribed format.
• Writes protocols and reports.
• Supports the V&V process to ensure appropriate verification and validation activities are completed.

Qualifications (title and compensation commensurate with experience)

Knowledge and Skills

• Experience and growing knowledge of medical device product development, from design input, conversion to specifications, conversion to test protocols to verify performance.
• Knowledge in common materials and manufacturing processes used for single use, sterile medical devices.
• Solid background in applying scientific principles to solve technical problems.
• General understanding of engineering documentation practices
• Excellent communication skills (written and verbal)
• Discusses ideas and engages in discussions constructively.
• Able to defuse and manage conflict across multidisciplinary teams.
• Experience with Solidworks or other 3D modeling software.
• Proficient in MS Office (Word, Excel, etc)

Education/Experience Requirements

• This is an early-career position requiring a minimum of an Associates Degree in engineering or science discipline, or equivalent experience.
• Minimum 2 years of industry experience with FDA or ISO regulated quality system
• Previous experience supporting the development or manufacturing of medical devices.

Position Details

• This is a full-time, on-site position based in Aspero Medical's office in Broomfield, CO.
• This is a hands on supporting role in development.
• Currently, Aspero is not able to sponsor any candidates related to immigration status.

Qualified Candidates, with experience in medical device product development, should respond with their compensation requirements and availability.