Product Development Engineering Specialist - Core Projects

Job summary

Develop and test mechanical or electromechanical medical device designs, maintain design specifications and controls, and lead invention disclosures and project planning. Coordinate with project teams, support regulatory compliance, and transfer products to manufacturing while improving production yields and development processes.

Job details

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. Key deliverables: 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. Education & Experience: 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 Specialized Skill or Knowledge: 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

What you’ll do

Develop and test mechanical or electromechanical medical device designs, maintain design specifications and controls, and lead invention disclosures and project planning. Coordinate with project teams, support regulatory compliance, and transfer products to manufacturing while improving production yields and development processes.

Requirements

Requires a degree in engineering or a related field and 5–10 years of product development and design experience; medical device or similarly regulated industry experience is an asset. Candidates should be proficient in medical device design tools and techniques, with skills in CAD, analysis, simulation, verification and validation, manufacturing design, prototyping, and project leadership.

Listed skills

• Root Cause Analysis · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical Device Design
• Mechanical Design
• Electromechanical Design
• Computer-Aided Design (CAD)
• Risk Analysis
• Tolerance Analysis
• Statistical Analysis
• Root Cause Analysis
• Finite Element Analysis (FEA)
• Computational Fluid Dynamics (CFD)
• Design Verification and Validation
• Design for Manufacture
• Materials Selection
• Prototyping
• Project Management
• Team Mentoring

Job areas

• Engineering
• Manufacturing
• Healthcare
• Management & Leadership

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