Director of Operations - Aspero Medical

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

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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

This is a non-executive position. This is a role in a startup, young, preprofitable medical device company with a very small team. Great visibility, but this position has limited support resources. We're looking for a self-started, goal oriented individual, that thrives in a "hands-on" do it all environment.

Reporting to the CEO, the Director of Operations is responsible for providing leadership for the company in the areas of manufacturing operations, manufacturing engineering, and working with RA/QA management, the areas of regulatory affairs and quality control. The position provides support to the Director of Engineering with product development efforts as requested.

Responsibilities

• Leads manufacturing development planning and implementation of Aspero’s products in development and commercialization.
• Creates contract manufacturing performance specifications, sources and selects the company’s contract manufacturing services partners for device production. The breadth of services may be limited/specialty, or broad including quality control, sterilization, warehousing, distribution, etc. The ultimate supply chain for Aspero products may be one or multiple contract manufacturing services providers.
• Monitors and reports on the status of production capability, inventory capacity, COGS and financial performance of the manufacturing operation.
• Helps executive management to plan and analyze strategic and financial models.
• Provides oversite to RAQA management function.
• Leads the manufacturing engineering efforts of the company, e.g. DFM (where needed beyond development engineering), cost reduction changes, etc..
• Enhance and/or develop, implement and enforce policies and procedures of the organization by way of systems that will improve the overall operation and effectiveness of the corporation.
• Establish credibility throughout the organization and with the Board as an effective leader within the company and strong supporter of the CEO role.
• Provide strategic financial input and leadership on decision making issues affecting the organization; e.g. support of evaluation of potential alliances acquisitions and/or mergers.

Knowledge and Skills

• Extensive knowledge of FDA's cGMPS and ISO 13485 regulations and previous experience with application to a small, startup medical device organization
• Extensive knowledge of product development requirements and expert in transition-to-manufacturing or new-product-introduction efforts associated with completing the development of products..
• Extensive knowledge of operational and manufacturing requirements for the medical device industry. Subject matter expert on PFMEA methods, Process Validation Plans (IQ, OQ and PQ) methodology.
• Extensive experience working with outsourced/contract manufacturing services providers.
• Excellent ability to work in collaboration with product development engineers and leadership that are interacting with the same manufacturing service providers.
• 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.
• Excellent project management skills.
• Supervisory skills include understanding of personnel regulations.
• Working knowledge of FDA QSR and EU medical device regulations including effective risk management.
• Thorough knowledge of 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.
• Can discuss ideas and engage disagreements constructively. Able to defuse and manage conflict across multidisciplinary teams.
• Advanced personal computer skills

Education and Previous Experience Requirements

• Bachelor of Science in engineering or science discipline (or equivalent experience with business degree) – Masters preferred
• Minimum 7 years in prior roles directing Class II medical device company operations in manufacturing, manufacturing engineering, quality, warehouse and distribution of inventory, and supporting customer service.
• Minimum 7 years of prior experience working within a company's FDA and ISO regulated quality system
• Minimum 7 years of prior experience supporting financial reports, quality metrics, cost analysis, and strategic planning
• Prior experience in a small organization, startup environment

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 target years of experience, education and skills. Aspero offers an attractive package of salary, bonus potential, equity, 401(k) participation, and benefits. The ideal candidate is a highly analytical leader who will join our senior management team. You will be responsible for leading the company's day-to-day business operations (managing budgets, ensuring operational compliance is followed, and addressing administrative issues).