At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.
AliveCor seeks an Operations Manager to join this exciting start-up that is changing the face of mobile health. This role is responsible for driving product quality, process and yield improvement, supporting new product introductions, capacity expansion and cost reduction projects, qualifying new processes and equipment at AliveCor’s contract manufacturers.
- Provide manufacturing/engineering support for AliveCor production lines at contract manufacturers (CMs)
- Work closely with Quality, R&D, and CMs to resolve any manufacturing issue in a timely manner
- Communicate regularly with Marketing, Commercialization, and Finance teams on forecast needs to feed back to CMs and suppliers.
- Perform troubleshooting on products/process problems as related to design, material or process. Generate and communicate any supplier complaints, NCs, and/or CAPAs
- Lead process and yield improvement projects
- Be the main point of contact for CMs in process qualifications and validations for all changes implemented in manufacturing and IQ/OQ/PQ for new process and new equipment
- Generate and review documentation (ECOs, WIs, etc.) required for changes to product or process
- Support new product transfer activities for manufacturing line
- Recommend and identify new components, processes, suppliers as needed for new and sustaining products
- Generate, monitor, and communicate CM operations and quality metrics to Quality, R&D, Marketing, Commercialization, and Finance
Qualifications and Skills:
- BS degree in Mechanical Engineering or equivalent educational experience
- At least 10 years of experience in process development and improvement in a fast-paced manufacturing environment
- Experience with contract manufacturers or suppliers in Asia a plus
- Experience with 3D CAD mechanical design preferred
- Experience with component manufacturing processes (including injection molding, machining, MIM) a plus
- Effective communication skills (verbal, written and presentation)
- Strong problem solving and data analysis skills.
- Experience in Medical Device Manufacturing (including GMP, MDD, ISO), familiarity with ISO 13485 a plus.
- Ability to travel outside the US (25%)
AliveCor is located in downtown Mountain View, CA. We are close to Caltrain and supply car and bike parking for employees. We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.
- Competitive salary and competitive stock options
- Flexible and generous vacation policy
- Maternity / Paternity Leave
- Excellent Benefits - employee 100% covered for medical, dental and vision
- Mobile reimbursement
- Stocked kitchen + weekly catered lunches
A supportive, collaborative group of people who understand that success depends on the team
AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.