Mechanical Engineer Jobs

Senior Mechanical Engineer

CAD$100 - 130k

Leading HealthTech Scale-up | Recent $4M funding round⚡

Toronto based

Want to work for a Scale-up that is currently revolutionising the HealthTech space?

We are partnered with a tech company who are dedicated to 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.

This company is developing 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 gynecological prosthetics 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! APPLY BELOW:

Responsibilities

• 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
• Lead product safety certification process (ex: IEC 60601-1) and human factors engineering.
• Compliance to quality standards as described by ISO 13485
• Lead engineering prototype builds and resolve assembly/testing issues throughout the pilot and final builds
• Implement design changes that will improve manufacturing processes for scalability
• Mentor junior and intermediate engineers, and lead sub-system design and development activities
• Assist with assessment of suppliers and part quality, including tolerance analysis, first article inspections, part traceability, and part risk level determination
• Drive product and design FMEA activities to ensure product quality
• 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
• Incorporate designs with functional, biocompatibility and sterilization considerations
• Translate high level user/project requirements into engineering product (functional and performance) requirements and specifications
• 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)
• Advanced 3D mechanical design from concept to feasibility evaluations to design for manufacturability and industrial design

Requirements

• Experience in electromechanical medical system design and development, such as ultrasound medical imaging, EEG/EMG, or medical pumps
• 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 external supplier management and parts qualifications activities
• Clear understanding and experience of DHF and DMR documentation
• 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.
• Experience with different manufacturing techniques such as metal stamping, injection molding, silicone molding, insert molding, rapid prototyping

Bonus Points

• Experience in ultrasound system design and working with implant-grade biocompatible materials
• Knowledge of manufacturing systems, processes, and emerging technologies
• 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
• Capable of conducting CAD (i.e., FEA, Mold Flow) simulations
• Reliability testing experience
• Certification in process and/or quality engineering

Benefits

• 401K, wellness and wifi perks
• Medical, dental, vision, and life insurance
• PTO, company-paid holidays, parental leave
• Competitive compensation
• Flexible, remote-first work culture

🌎 The role is based in USA

📧 Interested in applying? Please click on the ‘Easy Apply’ button or for a confidential chat – [email protected]

• ⚡ Storm3 is a HealthTech recruitment firm with clients across London, Europe, and North America. To discuss open opportunities or career options, please visit our website www.storm3.com and follow the Storm3 Linked In page for the latest jobs and intel