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 advanced gastroenterology specialties. These endoscopy accessory products are specialty endoscopy overtubes that facilitate current and new, less invasive procedures in advanced 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 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 with a current team of nine (9) staff positions and supported by several outsourced service provider/partners. Company growth is expected to approximately double over the next 18 months under a business plan to establish commercial traction for the three products in our line as we develop relationships to engage a strategic partner for global distribution.
Role Description
This is a role in a startup, young, pre-profitable medical device company with a very small team. Great visibility, but this position has limited support resources. We're looking for a self-starter, goal oriented individual, that thrives in a "hands-on" do it all environment. This role will bring a deep knowledge and broad experience of the regulated operational aspects of Class II medical device production to the leadership team.
Reporting to the CEO, the VP, Operations (VPO) will lead Aspero's operations, including manufacturing support of engineering/product development, outsourced production of Class II devices, quality, regulatory, logistics (warehousing, distribution, facilities, support of customer service), procurement and other responsibilities at the request of the CEO. The VPO works closely with the CFO/Controller in financial modeling, forecasting expenses and cash flow reporting. The VPO oversees the company's QMS, directly and through delegation, for its compliance with applicable regulatory requirements. This position leads the oversight of regulatory submissions (as tasked) for the companies regulated medical devices. This individual will oversee all internal human resource functions (recruiting, payroll, benefits, labor cost tracking, and employee relations).
Responsibilities
Responsible for all human resources activities. Source and create a high-performance organization in a hybrid structure comprised of direct employees (per approved staff plans) and outsourced services providers and contractors. Manage all services associated with recruiting, payroll, benefits and employee issues.
Source and leverage technical and manufacturing expertise via contractors and consultants, combined with hands-on activities to support R&D in the development of the company's products.
Responsible for all aspects of production of Class II devices, warehousing, distribution and procurement. Source and leverage contract manufacturers for production of the company's products including prototypes and test samples during development. Source and leverage services for logistics, purchasing and A/P processing in collaboration with the CFO/Controller to support financial planning and reporting.
Responsible for all aspects of the company's regulatory compliance and submissions. Source and leverage experienced consultants (or employees) to support the company's needs in QMS management, design assurance and regulatory filing, submissions and audits.
Support the CEO for grant and investor fundraising activities.
In collaboration with the CEO, develop and communicate operating plans that align with corporate goals and objectives and drive the company's business success.
Foster a culture of collaboration, accountability and high performance. Display and practice a visible, open leadership style throughout the organization. Provide critical direct support to the CEO as requested.
Work collaboratively with internal teams to provide feedback in a variety of internal processes, including new product development, customer service, order fulfillment and quality. Lead by example.
Knowledge and Skills Required Note, candidates without these credentials should not apply.
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 FDA's Design Control product development requirements and expert in transition-to-manufacturing or new-product-introduction efforts associated with completing the development of Class II medical devices.
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 medical device manufacturing services providers for procurement of components, assemblies, and turnkey finished products.
Excellent ability to work in collaboration with product development leadership and staff that are interacting with the same manufacturing service providers.
Knowledge in common materials and manufacturing processes used in sterile disposable medical devices. Experience with design and fabrication of thermoplastic polymers and 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 to achieve objectives.
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 a business degree)
Minimum of 10 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 of 10 years in prior roles supporting medical device product development, manufacturing transition from R&D, and new product introductions.
Minimum of 5 years with oversight responsibilities for company's QMS under FDA and ISO regulations
Minimum of 5 years of prior experience supporting financial reports, quality metrics, cost analysis, and strategic planning
Demonstrated ability to manage (hire and fire) a direct team of managers, engineers, and service providers.
Prior experience with early stage, e.g. startup, medical device companies and commercialization of products operating under financial and resource constraints and challenging schedules.
Prior experience with support of human resources, employment issues and administration of payroll and benefits, etc.
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 (as listed above). For purposes of screening potential candidates, compensation should be considered in a range of $180-$195k base annual salary within a small, preprofitable company with great potential. Aspero offers an attractive compensation package including bonus potential, equity (options), 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) and directly supporting the CEO.