07 Nov
|
Inertia Product Development
|
Toronto
07 Nov
Inertia Product Development
Toronto
Manager, Product Manufacturing We are looking for an engineer with deep manufacturing process knowledge and strong project and people leadership to lead new product manufacturing at Inertia. You will take products from engineering release through design transfer, process validation, pilot build, and production, working across our ISO 13485 and ISO 9001 facilities in Toronto and our sister manufacturing entity in Guangzhou. Much of this work is in medical devices and diagnostics, where manufacturing readiness and quality records are part of the product, with the balance in cleantech and industrial hardware.
In this role you will lead complex, high-value manufacturing programs, work directly with clients and suppliers, own the quality plan for each program, and help evolve the practices and systems that let Inertia carry products through to launch and scale.
Inertia Group is a Toronto-based product strategy, engineering, and manufacturing company. We help scaling hardware companies, regulated product manufacturers, and OEMs turn complex product challenges into manufacturable, launch-ready outcomes. Our work is concentrated in medical devices, diagnostics, cleantech, and industrial hardware, where technical depth, regulatory rigor, and manufacturing readiness decide whether a product succeeds.
Unlike firms that stop at design or hand off at the factory door, Inertia carries products through the full journey: validating demand, engineering with discipline, and building manufacturability and quality in from the start. We operate ISO 13485 and ISO 9001 certified facilities in Toronto, with manufacturing capability extending through our sister entity in Guangzhou.
For the people on our team, that means working across the whole product journey rather than one slice of it, and seeing the things you build reach production and the people who use them. Manufacturing readiness and design transfer Lead manufacturing programs from engineering release through design transfer, pilot build, process validation, and production, so that products reach manufacturing validated, documented, and supportable.
Build and own the quality plan for each program, scaled to its quality tier, including DMR and DHR structure, pFMEAs, control plans, inspection plans, and work instructions.
Plan and execute process validation (IQ, OQ, PQ) and production part approval with the engineering and quality teams.
Drive DFM and DFA reviews, make-versus-buy decisions, and cost modeling during engineering, so manufacturability and cost are built in rather than discovered at the factory.
Manage scope, budget, schedule, quality, and risk for complex manufacturing programs with a combined value of $1M to $2M per year,
and keep clients informed through clear, frequent communication.
Qualify, manage, and audit suppliers and contract manufacturers in Canada and offshore, including supplier controls under ISO 13485.
Coordinate production planning, builds, and sustainment across Toronto and our sister entity in Guangzhou, including travel to our Guangzhou facility and to suppliers.
Manage manufacturing change control, nonconformance, and CAPA for the programs you lead, and support client and regulatory audits.
Own quality tier assignment at proposal stage, and contribute manufacturing scope, cost, and schedule estimates to proposals.
set clear expectations, manage performance, and coach each person toward their own goals and Inertia’s.
Build a team environment that is supportive, demanding, and open, where people raise risks early and ask for help before problems compound.
Use and strengthen Inertia’s Quality Management System and project management practices, and lead continuous improvement in how we take products to production.
Actively support workplace health, safety, and wellness, and perform other duties as assigned.
A university degree in Mechanical, Mechatronics, Industrial, or Electrical Engineering, or an equivalent combination of education and experience.
10+ years of progressive experience in the production of complex electromechanical products, including 4+ years in an ISO 13485, FDA-regulated, or equivalent quality environment.
4+ years leading manufacturing programs from early customer engagement through design transfer, production, and sustainment.
Manufacturing readiness and quality Hands-on experience with design transfer, process validation (IQ, OQ, PQ), production part approval, pFMEAs, and control plans.
Working knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971 as they apply to manufacturing.
Broad knowledge of manufacturing methods for mechanical, electronic, and assembled products, and the judgment to choose the right one for the volume and the risk.
Experience with change control, nonconformance, and CAPA processes, and with preparing for customer and regulatory audits.
A record of managing scope, budget, schedule, and risk on complex programs, with the financial acumen to forecast, monitor, and report.
Proven ability to work directly with external clients and suppliers, including supplier qualification and performance management.
Competence with mechanical and electronic CAD tools, PDM or PLM systems, and project management tools such as Jira.
The discipline to keep documentation complete and current, because in regulated manufacturing the record is part of the product.
Transparent written, visual, and verbal communication that engages and educates stakeholders at every level, from technicians to client executives.
Strong assets, not requirements Direct experience manufacturing medical devices or diagnostics, including cleanroom or controlled-environment assembly.
Experience in cleantech or industrial hardware.
Supplier networks in Canada and in Asia, and experience working with offshore manufacturing partners.
Experience scoping manufacturing work and quality plans at the proposal stage.
Is as comfortable in front of a client as you are on the production floor.
Takes ownership of outcomes and raises risks early, before they become problems.
Communicates ideas clearly, in writing, in drawings, and in person.
Loves learning and helps the people around you grow.
We have built our culture on openness, service, and integrity, and Inertia has been certified as a Great Place to Work for nine consecutive years based on our practices and independent employee survey results.
What is harder to find is the work itself: products that reach production and the people who use them, in medical devices, diagnostics, cleantech, and industrial hardware, where getting it right matters.
You will work across the whole product journey, from first client contact through engineering, validation, and production, rather than one slice of it. Inertia is committed to building a diverse team and a safe, inclusive workplace. We are still learning and improving, and we welcome people who want to help.
Employment Type: Full Time
Primary Work Location: Hybrid, based out of our office at 34 Kern Road, Unit 3, Toronto, Ontario, Canada. This role requires regular time on site to support builds, suppliers, and the team. Occasional travel, including international travel to our Guangzhou facility and to suppliers, is required.
Compensation will reflect knowledge, skills, experience, and market conditions, and is supported by external benchmarking and internal equity.
Phone screening with Human Resources
Remote or in-person interview with the VP Manufacturing and an Inertia team member
In-person interview with two to three Inertia team members, where you present a past manufacturing program from engineering release through production
📌 Manager, Product Manufacturing (Toronto)
🏢 Inertia Product Development
📍 Toronto