Mechanical Engineer

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 Personalize 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 to Personalize Pelvic Health!

Role Summary
Cosm Medical is seeking a  Mechanical Engineer  to support the development and commercialization of our  Gynethotics  platform— the world’s first personalized gynecological devices. This role will be responsible for  proof of concept, design feasibility, development, prototyping, and BOM lifecycle management  while ensuring manufacturability and compliance with  ISO 13485  and  FDA  and other regulatory guidelines. You will work cross-functionally with software, production, and clinical teams to develop and scale next-generation medical devices.

This is a  hands‑on, impact‑driven role  in a fast‑paced startup environment. The ideal candidate has strong experience in  medical device design, manufacturing processes, and quality systems , with expertise in translating biomechanics and diagnostic parameters into engineering design, and is eager to bring innovative healthcare solutions to market.

Job Description
Responsibilities

Translate  clinical and user requirements  – including clinician  feedback , diagnostic  imaging  (e.g., ultrasound), and  biomechanics  – into  personalized device design  methodologies and functional prototypes.

Develop and refine  3D CAD models , design heuristics, and tools to guide shape selection,  parameterization , and  manufacturable design , incorporating industrial design principles.

Lead device testing, evaluations, and iterative improvements based on anatomical function, clinical studies, and regulatory feedback.

Conduct  physical testing  (compression, bending, cyclic loads), FEA and/or mathematical modeling, to optimize device performance.

Maintain  Design History Files (DHF) , perform  risk analyses (FMEA) , and ensure compliance with  ISO 13485 ,  IEC 60601/62366  (safety and usability engineering), and  FDA requirements .

Investigate  root cause issues  and drive corrective actions related to product quality and manufacturability.

Work closely with leadership on  intellectual property (patents)  and novel product innovations.

Collaborate on  automated software workflows , integrating digital health and custom manufacturing solutions.

Support  process development , including tooling, 3D printing, silicone injection, and other manufacturing techniques.

Assist in supplier assessments, part quality verification, and process validations.

Qualifications and Skills

B.Eng or M.Eng in Mechanical Engineering, Biomedical Engineering, or related field .

5+ years of experience  in medical device development, from concept to production.

Expertise in CAD software  (Solid Works, Fusion 360) and  Design for Manufacturing (DFM) .

Experience with  3D printing, injection molding, silicone molding, and high‑precision manufacturing .

Knowledge of  biomechanics, biocompatibility, and sterilization considerations .

Strong understanding of  ISO 13485, FDA regulations, and risk management (FMEA, validation protocols) .

Hands‑on experience in  physical and computational testing (FEA, mechanical testing) .

Strong problem‑solving skills and ability to work independently in a fast‑paced startup environment.

Excellent documentation and…