How to Apply:

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Description:

Senior Mechanical Engineer will be responsible for proof of concept, design feasibility, 3D/2D development, prototyping, alpha/beta evaluations, and BOM lifecycle management of mechanical devices and complex system design. He/She will be also responsible for leading in process development, including tooling design, to ensure consistent and high-quality parts are manufactured from 3D printing, silicone injection processes, injection molding and stamping. 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 process engineering, and work with equipment such as a Form 3B 3D Printer, Starrett Mechanical Test Machine, device production scale up, equipment and much more.

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Responsibilities:

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

• Advanced 3D mechanical design from concept to feasibility evaluations to design for manufacturability and industrial design

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

• Incorporate designs with functional, biocompatibility and sterilization considerations

• Develop solutions incorporating biomechanical end use conditions with expert level of mechanical engineering input

• Mentor junior and intermediate engineers, and lead sub-system design and development activities

• Structural assessment of designs through FEA, mathematical modeling, or 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)

• Work alongside leadership team, marketing, and the entire organization to ensure alignment on project priorities and outputs

• Implement design changes that will improve manufacturing processes for scalability

• Provide input to new equipment specifications and manufacturing processes (e.g., tooling design and IQ/OQ/PQ)

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

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

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

• Drive product and design FMEA activities to ensure product quality

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

• Effective communication with other team members, stakeholders, 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

• Work with leadership team on novel patent submissions

• Other assigned tasks

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Knowledge, Skills & Abilities:

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• Senior mechanical engineer able to apply innovative solutions to real-world scenarios

• Expert CAD designer - experience with Fusion 360, SolidWorks, and Finite Element Analysis (FEA) considered assets

• Expert level design for manufacturing (FDM) and industrial design

• Advanced knowledge of medical device manufacturing processes for medical consumables and hardware including but not limited to 3D printing, injection molding, extrusion

• System design and development experience is a plus

• Experience in manometry system design, pump design, fluid mechanics

• Ability to work with internal and external stakeholders to drive project success

• Ability to communicate with transparency and always maintain integrity and honesty

• 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 quality management system (ISO 13485, IEC 60601, 62304, 62366)

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

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Education & Experience:

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Must have

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

• Must have a minimum of 3-5 years of experience with new product introduction to commercialization of medical devices with complex mechanical architecture

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

• Experience in electromechanical medical system design and development, such as ultrasound medical imaging, EEG/EMG, or medical pumps

• Clear understanding and experience of DHF and DMR documentation

• Experience with different manufacturing techniques such as metal stamping, injection molding, silicone molding, insert molding, rapid prototyping

• Experience in external supplier management and parts qualifications activities

• Critical thinking skills: recognize, build and appraise arguments, identify inconsistencies and errors in reasoning, break down complex problems into actionable tasks/ goals, and communicate plans to resolve issues to the project team and upper management.

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Nice to have

• Certification in process and/or quality engineering

• Knowledge of manufacturing systems, processes, and emerging technologies

• Experience in ultrasound system design and working with implant-grade biocompatible materials

• Reliability testing experience

• Capable of conducting CAD (i.e., FEA, Mold Flow) simulations

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

• Experience (minimum 3-5 years) with fabricated metal components, plastic injection product enclosures, and electrical-mechanical interfaces

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Physical Requirements and Environmental Conditions:

• Requires hands-on use of equipment for building mechanical test jigs and devices

• Requires to be on-site with the occasional work-from-home with prior manager’s approval

• Light to moderate work with 15 pounds maximum weight to lift and carry

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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.

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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.