Product Development Engineering Specialist

Job summary

Design and test mechanical or electromechanical medical devices, maintain design-control documentation, and develop project plans and invention disclosures. Coordinate with project teams, support manufacturing transfer and continuous improvement, and ensure products meet regulatory, quality, cost, and production targets.

Job details

At Trudell Medical International (TMI), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world. Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture. As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals. We’re actively searching for our next team member for the position of: PRODUCT DEVELOPMENT ENGINEERING SPECIALIST Job Purpose Deliver innovative medical device designs that provide exceptional value to our patients. Demonstrate proficiency with the tools and techniques of medical device design while developing mentoring skills to guide less experienced engineers. Influence functional teams to deliver new product development projects on plan, within target costs, and that meet or exceed our expectations for quality and innovation. Responsibilities Include DESIGN DEVELOPMENT & TESTING With oversight from Senior, Principal Engineer or Product Development Project Lead, design mechanical or electromechanical solutions to support device design Act as Design Responsible Engineer (DRE) and maintain and create the Product Design Specification and all design controls Apply standardized problem-solving tools to identify a design problem and propose solutions before implementation DEVELOPMENT PROCESS Develop full invention disclosures within the Intellectual Property development process as lead inventor Develop complete project plans that accurately reflect the scope and deliverables required for a given project Deliver continuous improvement initiatives that improve aspects of the new product development process as part of a continuous improvement team Transfer product to manufacturing and revise design/process based on feedback until the product has reached target production yields and throughput COLLABORATION With support from Senior, Principal Engineer or Product Development Project Lead, plan design to achieve a developed product Coordinate with Product Development Project Lead to align design and development tasks to the overall project plan REGULATORY & POLICY Deliver device development projects in full compliance with all applicable standards, regulations, and policies to achieve clearance. Adapt to and challenge regulations as appropriate to find the best path to clearance HEALTH & SAFETY Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc. Qualifications Degree in Engineering (Mechanical, Mechatronic, Biomedical) or a related field of study 5-10 years of product development and design experience Medical device industry experience, or a similarly regulated field, is an asset CAD (Parts, Assemblies, Drawings, PDM, etc.) Analysis (Risk, Tolerances, Statistical, Root Cause, etc.) Modelling and Simulation (FEA, CFD, Mathematical, etc.) Design Verification and Validation (Test Design, Functional, Usability, Compliance, etc.) Design for Manufacture (Molding, automated assembly, packaging, etc.) Materials selection (Polymers, additives, properties, safety, etc.) Costing (COGS) Prototyping (3D Printing, Electronics, Traditional, etc.) Programming (Python, Matlab, Arduino…etc.) Electronics (prototype PCB or breadboard, component selection, test, etc.) Experience with mentoring and leading teams Project management experience Proficient with tools and techniques of medical device design At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities. Trudell Medical International is committed to providing fair and equitable compensation opportunities to all teammates. The range displayed on each job posting reflects the target for new hire salaries for the advertised position. Within the range, individual compensation is determined by job-related skills and knowledge, relevant professional, lived experience, and/or work location. Our compensation policies and practices are designed to allow our colleagues’ growth and salary progression as they develop in their role. As a candidate, you are encouraged to ask compensation-related questions and have an open dialogue with your recruiter, who can provide specific details for this role and share more information about our total rewards package. As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team. We are an equal opportunity employer and it is important to our Company that all its employees, including those with disabilities, find our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodations during the recruitment process, please let us know.

What you’ll do

Design and test mechanical or electromechanical medical devices, maintain design-control documentation, and develop project plans and invention disclosures. Coordinate with project teams, support manufacturing transfer and continuous improvement, and ensure products meet regulatory, quality, cost, and production targets.

Requirements

Requires an engineering degree in mechanical, mechatronic, biomedical engineering, or a related field, along with 5–10 years of product development and design experience. Candidates should be proficient in medical device design tools and techniques, with experience in areas such as CAD, analysis, verification and validation, manufacturing design, prototyping, project management, and mentoring; regulated-industry experience is an asset.

Listed skills

• Problem solving · Preferred
• Regulatory Compliance · Preferred
• Root Cause Analysis · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical Device Design
• Mechanical Design
• Electromechanical Design
• Design Controls
• Product Design Specifications
• Problem Solving
• Project Planning
• Intellectual Property Development
• Manufacturing Transfer
• Regulatory Compliance
• CAD
• Risk Analysis
• Tolerance Analysis
• Statistical Analysis
• Root Cause Analysis
• Finite Element Analysis

Job areas

• Engineering
• Manufacturing
• Healthcare
• Management & Leadership

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