Avail Medsystems is a pioneering medical technology company that is reinventing how medical procedures are supported by industry and clinicians. We are committed to delivering HIPAA compliant real-time video conferencing solutions that improve the quality, and lower the cost, of procedural care delivery. Our first-generation Avail Systems are currently being used to support procedures in the United States. Physicians are able to instantly connect with enhanced on demand support that is better than being there, with added capabilities such as the ability to annotate over live or paused video. We are looking for self-starters, who are good team players, to join us as we transform when, where and how procedural support is delivered.

Position Overview

Scale and lead an outsourced manufacturing operations capability that closely aligns with Avail’s rapid growth and related goals. This position will report directly to the CEO. Partner with R&D and other key cross-functional teams to scale the optimal, leveraged supply chain: global CM/ODM, 3PL, and multiple, global strategic Materials vendors. Build a lean, direct team to orchestrate and own the following:

Responsibilities

• Lead, manage and grow our Manufacturing Infrastructure
• Work with R&D and Product Management to confirm current and future hardware product requirements; ensure corresponding supply chain partner capabilities (TQCAB—Technology, Quality, Cost, Availability, ease of doing Business) meet or exceed needs.
• Work closely with the NPI (new product introduction) cross-functional team and supply chain partners to ensure all key manufacturing readiness elements are defined and completed, on-time: manufacturing engineering (DfM, test, quality/reliability, process, product data/change management), materials pipelining, cost, product demand planning, security, product fulfillment, RMA.
• Successfully orchestrate the scaling of product contract manufacturing, configuration, fulfillment and RMA from the current small scale NPI leveraged model, to an optimal, global and scalable model. Work closely with the R&D team, our existing CM partner and key component suppliers, and emerging partners to ramp the required product, process, and systems elements.
• Manage the ongoing, day-to-day manufacturing engineering, operations, fulfillment, logistics and RMA deliverables. Ensure best practice metrics and related goals are effectively determined, managed and met to align with the needs of Avail’s overall business goals.
• Manage and drive results and operational efficiency across all aspects of Safety, Quality, Deliveries and Cost

Qualifications

• Bachelor’s Degree required in (ideally) Engineering
• Medical device manufacturing operations experience preferred.
• Taken a product through the FDA device application process for all three regulatory classes, Class I, II and III and familiar with the steps and pathways to approval.
• Self-starter, with at least 8+ years’ leadership experience in a technology OEM with an outsourced manufacturing model structure, in engineering (NPIE, test, process, quality, etc.) and/or commercial (supply chain management, demand planning, commodity management, etc.) roles.
• Strong preference for demonstrated manufacturing engineering (test, NPI, process, quality) and/or commercial domain expertise, as an individual contributor, cross-functional program manager, and people manager.
• Experience working in high-growth, technology OEM companies, including start-ups, with established global supply chains that include, ideally, CM/ODM manufacturers and global 3PLs.
• Demonstrated ability to work cross-functionally (with R&D, Finance, Product Management, HR, Sales, Support, etc.) to ensure successful hardware product manufacturing, fulfillment and RMA for a global customer base.
• Prefer experience/exposure on the commercial side of operations (inventory management, supplier business relationship management, procurement, demand planning, logistics, cost reduction).
• Strongly motivated and capable to get to the next level of manufacturing leadership and responsibility in a dynamic start-up environment, leveraging strong, applicable manufacturing engineering domain expertise.
• Ability to lead strategic initiatives while being a strong hands-on individual contributor
• Willingness to travel, when applicable, in North America and worldwide.

Location: Santa Clara, CA

Avail Medsystems provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.