- Title: Director, Manufacturing
- Full time
- Reports to Chief Operating Office & Director of Product Development & Engineering
Zephyr Sleep Technologies
#102, 701-64th Avenue SE, Calgary, Alberta
You will be working on the Operations team of a small medical device company in a dynamic and collaborative environment. You will be responsible for the manufacturing of the MATRx Plus, a home-based and cloud-connected medical device. The MATRx Plus is comprised of a number of components, some sourced and others assembled in-house. This medical device is tested and calibrated on-site. We are looking for a candidate to manage a small team of technicians and manage a relatively small supply chain. As the Company’s products are approved by Health Canada and the FDA, compliance with medical device standards is required (MDSAP and 13485 (2016). The Company intends to also release products for sale in Japan, the EU and Australia. Production is currently 25 systems per month and we’re looking to ramp up production to 150 systems per month by June, 2019.
Areas of responsibility will include:
- Responsible for the overall direction, coordination and evaluation of manufacturing activities conducted by the company or contract manufacturers
- Develop and implement manufacturing process plans including requirements for risk management, verification, validation, monitoring, inspection and testing to ensure quality objectives, requirements for the product and regulatory requirements are met
- Responsible for overall management of DMR development and maintenance activities
- Supervise the manufacturing activities, including the transfer of design to manufacturing, through close collaboration with company personnel and external parties
- Responsible for ensuring that product is manufactured, inspected and tested in accordance with plans
- Ensure delivery commitments are met without compromising quality or regulatory compliance
- Oversight of purchasing controlled product, PO Log and record maintenance and product receiving activities
- Support work with suppliers to put in place required contracts and Quality Plans
- Responsible for managing contract manufacturers
- Oversight of RMA management
- Oversight of Controlled Product management
- Ensure that products and prototypes used in clinical investigations are manufactured in accordance with Quality requirements and that their use is supported in the field.
- Responsible for product identification and traceability
- Responsible for approving Sales Orders
- Ensure products are delivered efficiently to the customer
- Oversight of product shipping
- Responsible for overseeing the maintenance of NCR / TDN records and Logs and confirmation of product disposition
- Support and contribute to the implementation and continuous improvement of design control processes and all processes related to Operations to support product development and re-engineering, manufacturing, distribution and customer support activities per the Quality Management System
- Develop quality objectives and establish department procedures that ensure customer and regulatory requirements are met
- Develop and monitor performance, efficiency and product quality standards for all engineering, manufacturing and distribution operations and initiate action to resolve problems
- Follow established quality procedures to minimize compliance risk and ensure commercial product integrity
- Actively participate in the appropriate management team(s), assisting with the development and realization of strategic and operating plans, budgets, goals and outcomes
- Provide vision and leadership for existing and emerging products, technologies, manufacturing and logistics
Manufacturing activities strictly adhere to approved work instructions and are carried out in compliance with an ISO 13485 certified quality management system. Training will be provided.
- Product Development and Engineering
- Finance & Accounting
- Quality Management
- Regulatory Affairs
- ERP and IT Systems
- Vendors and suppliers
EXPERIENCE & EDUCATION
- Technical undergraduate degree in engineering
- Member of APEGA (P.Eng. or E.I.T) in good standing
- 3-5 years of experience in a management position in a medical device manufacturing environment
MAJOR QUALIFICATIONS REQUIRED TO SUCCEED IN THE JOB
- Strong analytical skills and a solutions-oriented mindset;
- Effective communication skills (verbal and written);
- Exceptional time and project management capabilities;
- Strong knowledge of Microsoft Excel and an Enterprise Resource Planning system;
- Ability to work with minimal supervision with the ability to perform in a fast-paced environment.
Zephyr Sleep Technologies (“ZST” or the “Company”) designs, develops and manufactures medical devices for diagnosis and treatment of sleep disordered breathing. Zephyr has launched its second generation product, the MATRx Plus, designed to fulfill the needs of a significant and expanding market in the US. The MATRx Plus is a tablet-based and cloud-connected medical device designed to be used at the patient’s home and is currently cleared by Health Canada for sale in Canada and by the US Food and Drug Administration (FDA) for sale in the US. The MATRx Plus medical device is used to complete a two-night home study which determines: i) If a simple oral appliance is capable of treating obstructive sleep apnea (“OSA”,; and, ii) a therapeutic position for the mandible. This information allows a dentist to custom make an oral appliance for an OSA patient.
Zephyr Sleep Technologies was founded in 2010 principally by Paul Cataford (CEO), John Remmers (Chief Medical Officer) and Sabina Bruehlmann (Director – Technology) and was spun out of the University of Calgary. Zephyr is a private company headquartered in Calgary Alberta with 36 employees. The intent is to grow the team to 55 by the end of 2019 Since inception, the Company has raised over $17 million – $6.7 million from investors and over $10 million from non-dilutive sources (government & strategic partners).
Partnership with DENTSPLY SIRONA (“D/S”)
On June 30, 2017 ZST closed a strategic investment with Dentsply Sirona (“D/S”), the largest dental technology company in the world. In addition to the investment, D/S is also “bundling” a MATRx Plus with each of its 3D AI – cone beam CT scanners in the US.
The MATRx is installed in 200 sleep labs and clinics in NA and over 12,000 tests have been completed since 2013. MATRx users include Kaiser Permenante in northern CA. The MATRx Plus has cleared Health Canada since the beginning of the year and is installed in close to 50 sites so far in Canada. The Company is now cleared by the FDA to sell the MATRx Plus in the US and has backlog of over $1 million. The plan is to be in 3,000-5,000 dentist offices by the end of 2020 bringing in annual revenues in excess of $35 million.
Keep it Simple
To help people live healthy and productive lives by sleeping better
- Do it right
- Find a way
- Work as a team
- Continually improve
- Be agile – work fast, smart and hard
If you would like to be a part of the Zephyr Sleep Technologies Team and you are interested in this exciting career opportunity, please send your resume to email@example.com. Please include “Director, Manufacturing” in the subject line. We thank all applicants for their interest; however only candidates selected for an interview will be contacted.