Welcome to ZiphyCare! We're grateful you're interested in learning more about us to consider joining our team. At ZiphyCare, we are challenging the status quo in healthcare delivery. We believe that cost-effective quality healthcare can be delivered directly to every home.
We are looking for a Director of Commercial Manufacturing who will
- Direct the research and development in order to meet the commercialization schedule.
- Scale up the current production processes to establish the production of Ziphy kits on-demand, on time.
- Manage relationships with parts suppliers, vendors and factories producing metal, plastic, foam and other parts.
- Manage the current process with the emphasis on producing documentation for CMs.
- Support the company's efforts as necessary to obtain ISO 13485 certification and CE Mark for its products.
- Actively participate in and perform duties for the company’s QMS and regulatory audits.
This is a remote position with some travel. This role will be involved in the pre-production (planning) stage as well as the production (control and supervision) stage. A large part of the job is dealing with people and resource management. The scope of work includes management of the processes, product design, purchasing, suppliers and manufacturers, production dependencies, risks; and active participation of the QMS. This role will oversee, manage and facilitate the hardware processes, production, hardware testing and deployments, and risk mitigation.
- Ability to create and adhere to production processes.
- Strong project management skills with the ability to prioritize multiple tasks.
- Strong communication skills with the ability to present results and recommendations.
- Excellent problem-solving skills, and a strong work ethic.
- Proven record in training employees about safety and production.
- Strong working knowledge of Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) regulations
- Operate effectively within cross-functional teams globally.
- Proven critical thinking skills and problem-solving ability.
- Must be able to provide solutions that reflect understanding the business objectives and cost implications.
- Ability to write reports legibly and accurately.
- Knowledge of manufacturing tools and equipment.
- Knowledge of and/or experience in regulated industries.
- Proficient in basic application software systems (Word, Excel, Outlook, etc. or Google equivalent), experience working with CAD programs.
Education and/or Experience
- Technical, Engineering or Business Administration Bachelor’s Degree. A high school diploma with relatable years of experience is acceptable.
- Managing production at scale 5-10 years. We are looking for someone with Management/Supervisory experience in an industrial field or manufacturing environment (e.g. service/repair facility operations) where managing a production department and team was required (people management, safety standards, cost, quality, and delivery).
- Formal ISO training/certification or hands-on operational experience in a certified ISO 13485 or ISO 9001 facility.
- Relevant training and certification in industrial production, engineering, or any related field.
- Understand one or more: Industrial design, mechanical engineering and electrical engineering.
- Nice to have: Electronics/Instrumentation background to include experience troubleshooting and repairing electronics and instruments, calibrating electronic instruments, interpreting technical manuals, electrical schematics, loop drawing, and wiring diagrams, and operating analog and digital oscilloscopes and multimeters and other tools used to troubleshoot and calibrate instruments.