Intermediate Mechanical Design Engineer

Intermediate Mechanical Design Engineer

Toronto, Ontario, Canada

How to Apply:

 

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.

Description:

 

The Intermediate Mechanical Design Engineer will be responsible for proof of concept, design feasibility, 3D/2D development, prototyping, alpha/beta evaluations, and BOM lifecycle management. You will be contributing towards successful CDI (Colpodynamic Imaging) and Gynethotics products by working on integrated designs to ensure consistent and high-quality imaging is obtained from our proprietary 3D measurement technology and design novel Gynethotics that meet our user and clinical needs. All work will be conducted in accordance with ISO 13485 and FDA regulatory guidelines.


The job will be located at Cosm’s manufacturing Lab at the MaRS Accelerator (101 College St.) in Toronto’s world-renowned Healthcare Technology hub alongside support within Cosm Medical as part of the Autodesk Residency Program within the same ecosystem. The candidate will expand their experience in medical device design, and work with ultrasound equipment, Form 3B 3D Printer, Starrett Mechanical Test Machine, and much more.

Responsibilities:

  • Translate high level user/project requirements into engineering product (functional and performance) requirements

  • Advanced 3D mechanical design from concept to feasibility evaluations to design for manufacture

  • Lead engineering prototype builds and resolve assembly/testing issues throughout the pilot and final builds

  • Incorporate designs with biocompatibility and sterilization considerations

  • Develop solutions incorporating biomechanical end use conditions

  • Structural assessment of designs through physical testing (such as compression, bending and cyclic load testing of devices)

  • Develop mechanical verification test protocols, lead in execution and report, including failure mode analysis and disposition, for Design History File (DHF)

  • Implement design changes that will improve product design or manufacturability

  • Assist in implementation of new equipment and processes into Manufacturing (e.g., tooling design and IQ/OQ/PQ)

  • Perform root cause analysis, verify and implement corrective actions as it relates to product quality issues

  • Aid in Purchasing, Material Handling and Inventory Tracking when necessary

  • Assist with assessment of suppliers and part quality, including tolerance analysis, first article inspections, part traceability, and part risk level determination

  • Support product safety certification process (ex: IEC 60601-1) and human factors engineering

  • Supports product and process FMEA activities to ensure product quality

  • Develop and monitor (day to day) mechanical timelines against project milestones. Report project issues to management

  • Effective communication with other team members and clients to ensure products are provided in a timely and efficient manner to meet R&D milestones and timelines

  • Compliance to quality standards as described by ISO 13485

Knowledge, Skills & Abilities:

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  • Mechanical engineer able to apply innovative solutions to real-world scenarios

  • Expert CAD designer - experience with Fusion 360 and parametric modeling

  • Ability to communicate with transparency and maintain integrity and honesty at all times

  • Ability to work independently and as part of internal and external teams including researchers, scientists, suppliers, partner companies and institutions

  • Gathers, organizes and presents information in a clear, concise, and compelling manner

  • High proficiency with Microsoft Office Suite (Word, Excel, PowerPoint)

  • Ability to work within medical device regulations and quality management system (ISO 13485, IEC 60601, 62304, 62366)

  • Project management skills to manage internal deadlines, co-ordinate with external vendors and clinical partners

Education and Experience:

  • Bachelor's degree (B.S.) or Master’s Degree (MS) from an accredited college or university in Mechanical Engineering; a combination of education and experience will be considered

  • Must have past (minimum of 3-5 years) experience with new product introductions, preferably with medical devices (or consumer products) with complex mechanical architecture

  • Expert (minimum of 5 years) in CAD and assembly design, GD&T, and BOM lifecycle management

  • Experience (minimum 3-5 years) with fabricated metal components, injection molding, extrusion, blow molding and/or electrical-mechanical interfaces

  • Past experience in ultrasound system design and working with implant grade biocompatible materials

  • Reliability Testing Experience

  • Capable of developing and execute mechanical development timelines from cradle to grave

  • Critical thinking skills; recognize, build and appraise arguments, identify inconsistencies and errors in reasoning, breakdown complex problems to actionable tasks/ goals, and communicate plan of attack to project team and upper management.

Physical Requirements and Environmental Conditions:

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  • Dynamic work environment with constantly evolving, occasionally high-stress, always ambitious goals

  • Flexible work from home is available for this role, however there will be a requirement to be on-site (downtown Toronto) during periods leading up to and during scheduled audits

Company Description:

 

Cosm Medical is a medical device company building a platform for Personal Pelvic Health to improve the lives of women affected by pelvic floor disorder. 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. 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 and quality of life.


At Cosm, we are developing Gynethotics™, or made-to-measure gynecological prosthetics, to replace pessaries and manage pelvic organ prolapse, incontinence and more. Our goal is to transform the art of pessary fitting into the science of Gynethotics™ by leveraging cutting-edge technologies like 3D printing, AI, cloud software, and point-of-care diagnostics. 

This is an opportunity to join our growing team that is leading the way in creating a new personalized medical devices category for underserved women’s health conditions. Join our mission for Personalizing Pelvic Health!


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.