Spectrum Medical Diagnostics $54,000 jobs

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 operate much like a fractional CTO for your clients - guiding them through the entire journey from concept to manufacturing launch with clarity, confidence, and care.

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.

What Makes Inertia Different

At Inertia, we don’t just build products - we build momentum.

• Exceptional Client Trust: Our clients consistently rate us above NPS 80, recognizing the precision, transparency, and results we deliver.
• 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.
• Culture of Growth: Our multidisciplinary team thrives on curiosity, collaboration, and continuous learning - pushing boundaries in engineering, design, and manufacturing every day.

For more information on Inertia please visit our website here: www.inertiapd.com.

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 >3 FTE contributors and/or external partners and consulting sales of >$750k per year.
• 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.g., FDA 510(k) or De Novo, Health Canada, EU MDR).
• 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.
• Coach team members in a supportive, challenging, and inspiring team environment.
• Actively participate and engage with external partners, industry groups, and organizations.
• Develop and encourage strong peer relationships across disciplines, teams, and geographies.
• 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.
• Actively support and promote workplace health, safety, and wellness.
• Perform other relevant duties as may be assigned.

Who we are looking for

You have:

• a university degree in a relevant engineering discipline (i.e., 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.g., 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.g., 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.
• strong analytical and problem-solving skills, with impeccable, detail-oriented documentation.
• an energetic and can-do attitude with ability to set realistic and attainable goals.
• work that garners praise from peers and customers and the tangible results to prove it.
• a passion and perseverance for all aspects of product design, engineering, and prototyping.

You are someone who:

• 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.
• likes to gather facts. You use them to help evaluate ideas and make balanced decisions.
• is great at communicating ideas – visually, verbally, and in writing.
• is the first to take on responsibility, the last to take credit (everyone gives it to you anyway).
• has a proven ability to develop constructive relationships with all internal and external partners.
• can work collaboratively, effectively, and efficiently without ego getting in the way.
• can tactfully and effectively address concerns or conflicts openly with the team and clients.
• has the persistence and resourcefulness to overcome project obstacles and drive to resolution.
• can deal with uncertainty in a constructive manner and generate options for moving forward.
• wants to make a real and positive impact on the people around you and the world at large.
• wants to be part of and help build a high performing team.
• does whatever it takes to get the job done. Without being asked.

Interested in Joining Our Team?

Our people are our single biggest advantage. We have a talented and motivated team looking for more great people to work and grow with. 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 Great Place to Work® for the last six years based on our practices and third-party employee survey results.

If you’re interested in becoming part of our team, learn more about our values at www.inertiapd.com. If you feel your values fit with ours, then we’re off to a great start...

What We Offer

Competitive compensation and benefits are just the start. At Inertia you will have the opportunity to help build the kind of experience and company you want to be part of. You’ll be treated as a part of the team from day one.

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.

We are big believers in continuous growth. You’ll have the opportunity to learn and grow, maybe more than any company you’ve worked with (our employees have told us so).

Friendliness and smarts are not mutually exclusive at Inertia. You’ll work with a diverse group of world-class team members that are open, collaborative, friendly and even a little whacky at times.

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. Must be legally permitted to work in Canada. Occasional international travel may be required.

Annual Salary: We are considering candidates with a variety of experience levels for this Team Lead or a Manager level role, depending on experience and capabilities. Salary offers are based on a number of factors including internal equity, applicant skills, prior relevant experience, and local market conditions.

Interview Process:

• Phone screening with Human Resources
• Remote or in-person interview with Hiring Manager + Inertia team member
• In-person interview with 2-3 Inertia team members where you present on a past project
• Offer, subject to reference calls

How to Apply: If this feels like a role and place where you will thrive, please follow this link to submit your application online via https://inertiaengineering.bamboohr.com/careers.

Learn More: Visit us at www.inertiapd.com and on LinkedIn at Inertia.