Head of Operations

 

Our Company, venture backed and currently in stealth mode, is a St. Louis-based digital health leader with a first-to-market non-invasive medical device and companion software targeting metabolic disorders. Launching in late 2019, we are a health and measurement innovator that provides the technology, feedback and adherence at the intersection of human behavior and chronic care management in areas like diabetes and obesity, with a platform that extends well into additional chronic diseases. Serving an enormous market with no direct competition with positive market trends as a tailwind, our FDA registered (Class 1) device fills a well-publicized biomarker gap for our clinical B2B partners in pharma and chronic care management, as well as an eager direct-to-consumer wellness market segment.

The Head of Operations, reporting to the CEO, is the Company’s most critical hire to support the fully-designed inaugural product launch and transition of manufacturing to internal and/or offshore resources. The position is a key member of the management team and compensated accordingly with an attractive compensation including stock plan. Functional areas of responsibility include engineering, manufacturing, QA, and logistics.

Responsibilities:

  • Plan and deploy quality management standard that will guide all aspects of product life cycle upon scientific handoff to shipment of device.

  • Establish best-practice document control process for software and hardware, working with regulatory and quality team to meet FDA requirements.

  • Manage schedule health by driving weekly meetings with manufacturing partner for build planning and readiness, with input and support from cross-functional leads.

  • Collaborate with cross functional teams and manufacturing partner to develop manufacturing processes, process flows, capacity model, equipment/ fixture designs, quality control plans, establish implementation schedules and validation plans prior to any Engineering build.

  • Represent all of Operations within the product design teams and the organization at large. Use previous experience to influence and negotiate for DFX, supply chain, testability, error proofing and simplification features.

  • Build and update essential BOM, COGS and ongoing parts management data in best-in-class software, built to scale.

  • Establish appropriate testing processes with appropriate documentation.

  • Manage hardware engineering for product return triage and research to support Chief Scientific Officer .

  • Research and lead manufacturing and engineering migration from current manufacturing partners to secondary vendor in US or Central America and Readout, respectively.

  • Design physical fulfillment space in new Readout offices for optimal workflow.

  • Hire and coach top-tier hardware engineer and quality control manager positions in advance of November targeted launch.

  • Set-up and oversee all logistical components from receipt of partially finished product to packaged device and white glove delivery to consumer or partner.

  • Expand our thought leadership efforts, demonstrating the value of novel data sources targeting adherence for purposes of real-world evidence and innovative patient/provider value.

  • Serve as an ethical member of the senior leadership team, being a responsible steward of our company's values toward patient care and placing the company's goals above any function or team member goals.

Minimum Qualifications:

  • Fifteen years manufacturing operations experience, at least seven years in managerial roles with increasing responsibility, primarily in medical devices. 

  • Demonstrated success in building out physical and software infrastructure for sourcing, parts management, inventory, and logistics of medical device.

  • Strong acumen in establishment of best practice QMS and device QA protocols.

  • Exceptional leadership skills with proven ability to create unfair advantages in what is traditionally a cost center.

  • Deep understanding of the digital health value chain, including clinical development, medical affairs, and first-to-market commercial launch in both direct-to-consumer and institutional market segments.

  • Deep understanding of complexities of provisioning/maintenance of distributed engineering & manufacturing partnerships.

  • Exceptional communication skills, demonstrated through an ability to synthesize disparate information in writing and in verbal interactions with team and senior leadership.

  • Bachelors Degree, Masters preferred.

Ideal Candidate:

  • Loves to solve problems in complex environments with a positive attitude.

  • Is motivated by start-up culture, wearing many hats while rowing with the rest of the team in an aligned strategy.

  • Highly disciplined as self-starter in unstructured environment, supporting teams outside of standard scope.

  • Thinks and acts “outside the box” throughout the day, using past experiences or competitive positioning as a framework only; has the confidence to boldly grasp and manage risk associated with novel deliverables and strategies; prefers to forge the path rather than follow.

  • Inspire others through action and build teams of high performing individuals with fierce loyalty to brand and company culture beyond software development.

  • Deeply aligned with Company’s vision to broadly impact patients and consumers with metabolic disorders; genuinely passionate about making a significant contribution to medicine that will impact a significant number of lives…today

  • Balance an optimistic view of the future with a pragmatic sense of what we can accomplish today in order to create meaningful, long-term value for our collaborators; very strong bias to action.

  • Maintains a high level of intellectual curiosity in a field that is constantly changing and where Company has “cracked the code”.

  • Comfortable in a dynamic workplace, knowing that our plan today will change frequently as market trends and milestones dictate; hired candidate is energized by change.

Readout is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind:  Readout is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.


To apply, please send your resume to info@readouthealth.com.