Head of Operations

ABOUT Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic. To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers JOB SUMMARY Truvian is seeking a highly motivated and passionate Head of Operations to join our Leadership Team. This leader is responsible for building, growing, and leading manufacturing, manufacturing engineering, supply chain, facilities, technical operations, and quality control functions. Your main goal will be to ensure that Truvian’s customers receive the highest quality products, on time, and in a responsive, efficient manner. This requires you to build and maintain a highly motivated workforce which pays strict attention to detail, can identify, develop and implement robust harmonized processes and procedures along with methods to ensure procedural compliance. You will foster a company-wide culture that emphasizes quality, reliable customer supply, service, safety, initiative, and a commitment to continuous improvement, demonstrated by every employee, every day. This is an onsite and hands-on leadership role. We will only consider LOCAL candidates at this time. Must have med device or IVD experience. HERE’S WHY YOU’LL LOVE THIS JOB: You will be setting the strategy and managing every aspect of Truvian’s Operations organization…there is a lot to do You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products. You’ll be a key leadership team member responsible for the company’s growth and product launch. You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape. You’ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount. WHAT YOU WILL DO: Broadly, this role is responsible for the delivery of Truvian’s diagnostic products into diverse, global end markets. This will require: Build and lead all aspects of Operations organization, including manufacturing engineering, automation engineering, production, supply chain, technical operations, facilities, and quality control functions. Plan and direct operational activities at Truvian to achieve shorter-term business targets as well as benchmark performance in the areas of quality, delivery, and cost. Build a long-term plan to achieve that vision, communicate the vision, and ensure staff alignment to work towards that vision. Act as a champion for the implementation of process improvements. Responsibilities for facilities, lab ops, and EH&S. Oversee manufacturing strategy and routine production for formulations and consumable assembly, fill, and finish. Lead the manufacturing cost of goods and capacity models and ensure that the manufacturing strategy can deliver the cost of goods targets. Collaborate in creating a long-range product roadmap to ensure manufacturing readiness. Define and own aggressive KPIs for quality, performance, delivery, and cost for all products. Work with R&D during development to ensure product manufacturability, scalability, and excellence. Build strong working relationships with vendors, partners, and CMOs and put in place robust supply agreements. Design, procure, commission, and sustain internal manufacturing capabilities as required by the strategy and in compliance with the QMS and FDA regulations. Scale the team to support the execution of the manufacturing strategy. Provide regular updates on progress against the plan to senior management and the board of directors. WHAT YOU WILL BRING: The ideal candidate will have extensive experience in: Achieving impossible timelines, through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast. Partnership and collaboration, ensuring relationships are the forefront of our strategy, emphasizing the company and team over personal goals. Communication, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace. Tools including experience implementing and working in ERPs, Microsoft Office products, and more. Problem-solving, with very strong analytical skills which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills. Required Bachelor in Life Science or Engineering; Advanced degree preferred with a minimum of 15 years of leadership experience in the Medical Device or IVD industries. Proven success in leading manufacturing ramp from pilot scale to a very high volume of high-quality and cost-effective parts. Previous work experience relating to immunoassays, chemistries, and/or plastic consumables. Strong knowledge of Good Manufacturing Practice (GMP) and FDA audits. Demonstrated experience applying operational best practices (Lean Six Sigma). Ability to mentor, follow, and give clear written and verbal directions with a high level of accuracy. Demonstrated world-class execution of complicated product launches on tight product schedules. Knowledge of design transfer best practices and scale-up of manufacturing processes. Strong analytical and problem-solving skills; must be organized and efficient. SUPERVISORY ROLE • Yes PHYSICAL DEMANDS AND ABILITIES Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear. Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance. Frequently required to stand, walk, stoop, kneel, crouch or crawl. Occasionally required to sit and climb or balance. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust and focus. If you want to stand out, please include a cover letter. Truvian provides equal employment opportunities to all employees and 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. 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