Production Operator
Toronto, Ontario, Canada
|
Full-time
Cosm Medical is a Toronto-based medical device company. Our goal is to transform the way pelvic floor disorders are treated thanks to 3D printing, AI and cloud software, and create Personalized Pelvic Health. Pelvic floor disorders, including pelvic organ prolapse, urinary and fecal incontinence, drastically decrease quality of life. These disorders are common (affects 1 in 4 adult women), growing (affects half of all women by 80 years of age) and underserved (stigmatized and traditionally low priority vs. other health concerns). The current non-surgical treatment for pelvic organ prolapse is the use of pessaries, which are intravaginal inserts that come in 100+ different sizes and shapes and are fit by trial and error, resulting in a relatively low success rate.
Cosm is commercializing the world’s first personalized pessary, Gynethotics™, or made-to-measure gynecological orthotics, improving patient satisfaction and outcomes compared to off-the-shelf devices, alongside a software platform to streamline the pessary practice.
Join our mission for Personalizing Pelvic Health!
Role Summary
The Production Operator will contribute to Gynethotics production by executing manufacturing tasks in accordance with product specifications, quality standards, and business objectives. Tasks include 3D printing, mold processing, silicone injection, curing, final device post-processing, coating application, labeling, packaging, and inspections. You will operate equipment, record data, and follow procedures in compliance with Cosm’s Quality Management System (QMS) under ISO 13485 and FDA guidelines.
The job will be located at Cosm’s manufacturing Lab at the MaRS Discovery District (101 College St.) in Toronto’s world-renowned Healthcare Technology hub and ecosystem. The candidate will gain practical experience in medical device production. This is a 100% in-person role.
Job Description
Responsibilities:
Perform post-processing, silicone injection, coating application, labeling, packaging, 3D printing, and fulfillment following standard work instructions and maintaining compliance with QMS
Perform incoming inspections, inventory tracking, and equipment maintenance/verification as assigned
Maintain DHR records to ensure full traceability of product
Set up, start, and operate production machinery in accordance with standard operating procedures (SOPs)
Observe equipment and processes to detect issues or malfunctions
Conduct regular quality checks to ensure finished products meet company standards
Perform general lab maintenance for upkeep and cleanliness
Promote and participate in JHSC initiatives and compliance as directed by the Joint Health and Safety Committee (JHSC)
Other duties as assigned
Qualifications and Skills:
High school diploma is required
Strong attention to detail and ability to follow instructions
High mechanical and hands-on aptitude are required
Accurate and clear documentation is required
Strong written and verbal communication skills with the ability to communicate with technical and non-technical staff is required
Ability to multi-task, prioritize duties, and execute tasks in a timely manner is required
Preferred:
Experience in a regulated industry such as medical device manufacturing
Previous experience in jewelry making, or buffing/polishing/grinding of fine details is preferred
Previous experience in a production or manufacturing environment preferred
Familiarity with ISO Quality Systems, GMP, and lean manufacturing
Experience in 3D printing and silicone injection
Strong troubleshooting skills and self-initiative
Physical Requirements and Environmental Conditions:
Dynamic environment with hands-on equipment use
Occasional lifting (up to 30 pounds)
To thrive in this position, you will have natural attention to detail, enjoy repetitive tasks, take pride in the quality of your work and personal effort, and possess a disciplined work ethic
Why Join Cosm Medical?
This is an opportunity to join our small and skilled team that is leading the way in creating a new personalized medical devices category for underserved women’s health conditions.
COSM is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
To apply, please send an email to ops@cosm.care. Please include the title of the position you are applying to in the subject line and attach your resume.