About Hello Heart: Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke – the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association’s Innovators’ Network and CVS Health Point Solutions Management platform. Visit www.helloheart.com for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes.

Responsibilities

• Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation
• Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones
• Create and maintain quality control plans across IQC, IPQC, and OQC processes
• Define and implement manufacturing process controls, test requirements, and build validation plan
• Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies
• Drive corrective and preventive actions and verify long-term effectiveness
• Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health
• Monitor yields, reduce defects, and drive continuous improvement across production lines
• Assess supplier capability and lead onsite production reviews and factory evaluations
• Define incoming inspection criteria, sampling plans, and supplier quality alignment
• Maintain detailed build documentation, quality dashboards, and audit reports

Qualifications

• 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline
• Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes
• Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma
• Proven experience leading root cause analysis and driving corrective actions
• Experience working with contract manufacturers and suppliers, preferably in Asia
• Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data
• Excellent communication skills with the ability to present findings and recommendations
• Experience supporting NPI builds and high-volume product ramp is preferred
• Familiarity with reliability testing and environmental qualification is preferred
• Knowledge of hardware system integration spanning mechanical and electrical components is preferred
• Experience with DOE, process optimization, or Lean Manufacturing is preferred
• Mandarin language proficiency is a plus

The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.