Senior Product Development 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 works with management through all phases of medical device product development, from concept generation to product launch, to develop new and improved company products. This includes technology development and feasibility assessments, design, prototype and test fixture fabrication, device and animal model testing, manufacturing process development, verification and validation, regulatory submissions and manufacturing transfer for commercialization. Evaluates and recommends specifications and ensures products meet the technical, functional and regulatory requirements. Pursues assigned tasks, with self-direction, within 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). Candidate must be versatile and flexible to work within an entrepreneurial company (wearing many hats and leading a diverse set of efforts) as well as bring their style strengths to further enhance our overall culture.

Responsibilities

• Supports product development planning, product development and executes project tasks, as requested by management.
• Works with other members of the engineering staff to ensure project milestones are met and tasks completed fully and on time.
• Follows reliable, efficient and cost effective procedures and approaches to complete assignments.
• Supports creation of comprehensive requirements and specification documents considering technology, regulations, marketing, and business needs.
• Supports creation of hazard analysis and risk mitigations documents. Supports selection among multiple possible risk mitigations.
• Supports creation of design specifications covering all aspects of design and acts as a primary resource in creating design outputs. Participates to ensure effective design reviews.
• Coordinates the procurement of materials, components, and services (fabrication, manufacturing, testing, etc.), to support product development efforts. Coordinates suppliers to meet project needs. Works with RAQA in matters of supplier management.
• Performs and monitors prototyping efforts and ensures the correct design aspects are being tested and evaluated.
• Champions process improvement in engineering, production, and quality. Originates design and design control related documents and champions improvements in documentation practices.
• Champions quality in the V&V process and ensures appropriate verification and validation testing takes place.
• Anticipates issues during transfer from design to manufacturing and suggests improvements to minimize issues during transfer and post-transfer.

Knowledge and Skills

• Experience and growing knowledge of medical device product development, from Voice of the Customer (user needs) to V&V to manufacturing for sterile, disposable products.
• Knowledge in common materials and manufacturing processes used in medical devices. Experience with design and fabrication of thermoplastic and thermoset polymers, to include elastomers. Experience with manufacturing processes such as extrusion, injection molding, coatings, polymer bonding and finished device assembly.
• Solid background in applying scientific principles to solve technical problems.
• Thorough knowledge of medical device engineering documentation practices
• Excellent communication skills (written and verbal). Earnest and self-directed, with the ability to work autonomously and communicate with teams working remotely and drive issues to resolution.
• Discusses idea and engages disagreements constructively. Able to defuse and manage conflict across multidisciplinary teams.
• Capable of planning tasks and resources.
• Proficient with Solidworks CAD (required)
• Advanced personal computer skills

Education and Previous Experience Requirements

• Bachelor of Science in engineering or science discipline – Masters preferred
• Minimum 7 years experience with product development of Class II devices within an FDA and ISO regulated quality system
• Technical experience on a medical device product development team, with involvement in all stages of product realization, from early stage concept generation to regulatory submission and product launch. Special emphasis will be placed on candidates with direct experience in requirements development, product design synthesis, design controls, verification and validation planning and testing, managing contract suppliers and supply chain development. 

Hours and Schedule

This is a full-time, on-site position. Hours may vary throughout the week, with the need to interface with external vendors in differing time zones within the US. Domestic travel may be required as needed for meetings and on-site work with Aspero’s outsource services partners and supply chain.

Compensation

Commensurate with experience, education and skills. Aspero offers an attractive package of salary, bonus potential, equity, 401(k) participation, and benefits. T