Vice President, Operations
- Posted: May 21, 2022
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Reporting to the Chief Executive Officer, the Vice President, Operations will lead all manufacturing, operations, and facilities functions for the Company.
Core Job Responsibilities:
- Direct all activities related to the acquisition of materials and services that will be used for clinical and revenue-generating products. This will include overseeing programs that ensure that all received products and services conform to specified requirements
- Maintain documented procedures for identifying materials from receipt and during all stages of production and delivery
- Ensure that production processes are carried out under controlled conditions. Provide means for continuous monitoring and control of process parameters, and perform validation according to established procedures, where results of processes cannot be fully verified
- Establish and maintain documented procedures for in-process inspection and testing activities in order to verify that specified requirements of product are met. Provide suitable means by which inspection and test status of product is identified
- Continuously monitor production costs/yields and standards to ensure that products are manufactured at the lowest costs
- Evaluate opportunities to cost effectively vertically integrate the manufacturing of company’s products
- Ensure that product that does not conform to specified requirements is prevented from unintended use
- Anticipates and resolves highest level issues and conflicts that could impact operations success
- Develops and maintains solid relationships with all functions of the organization and possesses the ability to resolve cross functional issues and appropriately influence these functions
- Provide manufacturing, quality, and materials support for all clinical builds
- Provide purchasing support company-wide
- Lead all engineering efforts related to the support and continuous improvement of manufacturing operations including Manufacturing/Process/Plant Engineering and Maintenance
- Recruit, hire, train, and develop staff to achieve company objectives
- Develop and implement the functional annual operating and capital budgets to meet long-term company and department objectives
- Effectively manage assembly, manufacturing engineering, materials, QA, and facilities
- Employ “best of best” manufacturing practices including JIT and continuous improvement
- Consistently meet all sales demands while maintaining quality levels
- Lead the transfer of new products from R&D to manufacturing
- Participate in the planning of short-term projects, long-term product development programs, and technology or business acquisitions
- Support the company’s Quality Policy and Quality System and participate in maintenance, continuous improvement, and periodic review of the Quality System, including plans and metrics, and their integration into the strategic and annual business plans
- Ensure that all manufacturing is in compliance with FDA, GMP, ISO 13485, and MDD/ MDR requirements
- Generate budgets, technology packages and RFPs
- Negotiate MSAs, WOs and SOWs
- Willingness and ability to travel as necessary
- Perform other duties as assigned
- Bachelor’s degree in Engineering, Supply Chain Management, Business Management or related field; or an equivalent combination of education and work experience. Advanced degree preferred.
- Minimum ten years of engineering and operations related experience and/or training, preferably with medical devices. Minimum five years of management experience
- Experience in launching and commercializing new products a plus
- Ability to organize and assimilate data/information to prepare contingency plans and future strategies
- Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
- Significant experience leading and implementing lean manufacturing / Six Sigma initiatives.
- Experience with ERP and MRP systems, preferably SAP
- Experience managing outsourced manufacturing relationships a plus
- Ability to work in a small company in a fast-paced environment, managing challenges and building consensus
- Eagerness to accept personal accountability while functioning as part of a management team which defines success as timely achievement of goals
- Strategic thinker, with the imagination and foresight to conceptualize new ideas and opportunities as well as the implementation skills to bring them to fruition
- Flexibility and self-reliance. Hands on experience developing, implementing, and upgrading operational systems and controls.
- Collaborative, intelligent strong leader with high integrity
- Thorough understanding of FDA Medical Device GMP, ISO 13485, and MDD/ MDR requirements.
- Demonstrated ability to optimize product design for purpose of manufacture and continuously improve production processes within a lean resource start-up environment
- Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
- Maintain corporate confidentiality at all times.
Living Avinger’s Culture:
As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:
- Patients first
- Be open-minded
AddressRedwood City, CA
BusinessView all jobs at Avinger