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 environment 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 concept all the way to product manufacture and customer delivery. ~ ability to apply mechanical and/or electrical engineering fundamentals and a systems engineering approach to new product development, including system requirements, interfaces, and traceability (user needs, design inputs, verification) throughout the design cycle. ~ the mindset and methods to ensure an end user/stakeholder centric perspective in your product development,



including human factors and usability engineering for clinicians and patients. ~ competence planning and managing work in an agile project management environment using project management tools like JIRA. ~ highly competent with mechanical and/or electronic CAD and engineering analysis tools (e.SolidWorks/Onshape, Altium), and skilled at executing or directing complex calculations, modeling, and simulation. ~ familiarity with and experience designing for a wide range of manufacturing methods, including processes and materials common to medical devices (e.injection molding, biocompatible materials, sterilization-compatible design). ~ proven ability to work directly with external customers and suppliers, backed by exceptional written, visual, and verbal communication and facilitation skills that engage and educate stakeholders at all levels. ~ work that garners praise from peers and customers and the tangible results to prove it. ~ is as comfortable in a customer-facing role as they are doing the technical work. loves learning, sharing knowledge, and helping others grow too. listens intently and reacts with careful confidence and humility.

You use them to help evaluate ideas and make balanced decisions. is great at communicating ideas – visually, verbally, and in writing. has the persistence and resourcefulness to overcome project obstacles and drive to resolution. wants to be part of and help build a high performing team. We’ve built an amazing culture on a foundation of openness, service, and integrity - that also makes for a great place to work. Inertia has been a certified Outstanding Place to Work® for the last six years based on our practices and third-party employee survey results.

At Inertia you will have the opportunity to help build the kind of experience and company you want to be part of. We create truly unique products and outstanding customer experiences. You’ll have the opportunity to be a key part of the customer journey, from first contact through to product delivery as Inertia works in all stages of the product development and manufacturing process.

Inertia is committed to building a diverse team and providing a safe and inclusive workplace. We are continually learning and growing, including in our efforts to improve diversity and build equity – come join us!

Employment Type: Full Time Primary Work Location: Hybrid based out of our 34 Kern Road, Unit 3, Toronto, Ontario, Canada office. Must be able to work in the office to support project and team needs as required. Occasional international travel may be required.

Salary offers are based on a number of factors including internal equity, applicant skills, prior relevant experience, and local market conditions. Phone screening with Human Resources In-person interview with 2-3 Inertia team members where you present on a past project

📌 Product Development Team Lead (Medical & Diagnostics) (Toronto)
🏢 Inertia Product Development
📍 Toronto