We’re looking for an experienced medical device product development engineer with exceptional project leadership, client management, and team coordination skills to join our talented team. In this role, you’ll act as the primary point of contact for the client
- responsible for nurturing the client relationship, managing the project, leading the multidisciplinary development team, and ensuring the technical success of every deliverable. You’ll thrive in a collaborative setting where complex medical devices, life science instruments, and diagnostic products are designed, verified, and transferred into production under design controls, with patient safety, quality, compliance, and customer satisfaction always top of mind. Inertia is a Toronto-based product innovation and manufacturing partner for medical device, diagnostic, and life science companies. We help ambitious startups and scaleups turn bold ideas into safe, effective, market-ready devices, guiding them from concept and prototype through design controls, verification and validation, regulatory approval, manufacturing launch, and production scale. Our fully integrated model unites strategy, engineering, and manufacturing under one roof, removing the handoffs that slow medical device programs down. With deep expertise in regulatory strategy, human factors, engineering design, design for manufacturing (DFM), and production, we make the complex simple and help innovators bring life-changing technologies to patients with speed and confidence. Lean, High-Performance Teams: We eliminate unnecessary layers of management bloat and empower our project leads to make decisions, move fast, and own outcomes. End-to-End Impact: You’ll see your work move from concept through regulatory clearance and launch,



with tangible results that improve patients’ lives. For more information on Inertia please visit our website here: Role Responsibilities As a Product Development Team Lead reporting to the VP Product Development, you will: Lead medical device projects through design controls, including user needs, design inputs, risk management, design reviews, verification and validation, and design transfer to manufacturing. Lead multiple simultaneous projects and/or large complex multi-disciplinary projects with the equivalent of Lead the creation, planning, and reporting of project scope, timelines, financial management, and performance. Collaborate with regulatory, clinical, and quality experts to align development plans with the target regulatory pathway (e.
Lead client meetings and all client communications including non-technical aspects such as billing, expenses, etc. Lead projects throughout the product lifecycle, from early concept and feasibility through development, regulatory approval, and manufacturing launch. Actively plan & consider how their project resourcing needs impact Inertia & the Inertia team, by seeking out additional (internal or external) resources when required and/or communicating when resources need to redeploy to other projects. Work closely with the Managers, Directors, or VPs in the creation of new project work orders, resources plans, pricing, and presentation to client.



Manage the trade-offs and relationships between technical, project, and human aspects of projects. Lead and manage your primary engineering discipline, with some ability in others Have and deploy a broad spectrum of knowledge to leverage many different types of resources, understand the dependencies/interactions between them and know when to ask for help. Manage direct report performance and coach team members to help achieve Inertia’s and their own goals. Use and promote Inertia’s Quality Management System to guide daily work, including design history file, risk management, and traceability documentation. Identify and implement continuous improvement opportunities. Biomedical/Mechanical, Electrical, Mechatronics) or equivalent combination of advanced education and experience. ~6+ years' progressive experience designing and engineering complex physical products, including hands-on medical device development. ~ experience developing medical, life science, or diagnostic devices within an ISO 13485 (or ISO 9001) quality management system and to FDA, Health Canada, and other regulatory requirements, including design controls, verification and validation, design transfer, and design history file documentation. ~ working knowledge of the product safety and performance standards that shape medical device design, including risk management (ISO 14971), electrical safety (IEC 60601), and usability engineering (IEC 62366). ~ comfort writing and executing supporting technical documentation such as biocompatibility assessments (ISO 10993), sterilization validation and test plans, and packaging and shelf-life test plans. ~ success managing multi-disciplinary engineering teams and projects, ideally new product development projects, from initial

📌 Product Development Team Lead (Toronto)
🏢 Inertia Product Development
📍 Toronto