Project Manager (Medical Consumables)

Location: Waterloo, Ontario

Position Vacancy Type: Newly created position.

Compensation Range: $100,000.00 - $120,000.00 per year

AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.

Every day, we help shape the future of healthcare. We design and build 3D tracking systems that equip medical devices with advanced spatial navigation technology, delivering greater accuracy, performance, and confidence in procedures where precision is critical. Since 1981, we’ve partnered with leading OEMs and research institutes to push the boundaries of surgical navigation. Our optical and electromagnetic technologies are trusted in procedures ranging from orthopaedics and spine surgery to cardiac interventions and radiation therapy.

Whether you're designing systems, supporting customers, or enabling the teams behind them, your work matters. It brings clarity to healthcare and helps improve outcomes for patients around the world.

THE IMPACT YOU’LL MAKE:

NDI is seeking a results-driven Project Manager (Medical Consumables) to lead the development of medical consumables for high-volume production in the medical navigation market. This role is ideal for a technically proficient, highly organized leader with experience managing projects in regulated medical-device environments, particularly involving consumable or single-use accessories.

You will drive cross-functional teams through the full product development lifecycle, ensuring delivery against quality, regulatory, cost, and schedule targets while maintaining strict compliance with medical device standards. This is an opportunity to contribute to innovative, patient-impacting products in a collaborative, high-performance environment that values continuous improvement and operational excellence.

HOW YOU’LL CONTRIBUTE:

• Lead the planning, execution, and delivery of medical consumables projects from concept through to production launch.
• Develop and manage detailed project plans, including work breakdown structures (WBS), schedules, budgets, and resource allocations.
• Coordinate cross-functional teams including Product Management, R&D, Manufacturing Engineering, Quality, Regulatory, and Supply Chain to ensure alignment and timely execution.
• Apply NDI’s Product Development Lifecycle and Design Control processes to ensure compliance with:

• ISO 13485
• FDA QSR (21 CFR Part 820)
• EU MDR requirements for accessories/consumables
• ISO 14971 risk management
• ISO 10993 biocompatibility

• Sterilization and packaging validation requirements (ISO 11135/11137, ISO 11607)
• Ensure proper documentation (DHFs, DMRs, 510Ks) aligned with global regulatory submissions.
• Identify, assess, and mitigate project risks to ensure successful delivery within scope, schedule, and budget.
• Communicate project status, risks, and decisions to stakeholders and leadership through clear and concise reporting.
• Support design for manufacturability (DFM) and scalability for high-volume production environments.
• Collaborate with Product Management and Operations to ensure market, regulatory, and manufacturability requirements are met.
• Partner closely with Regulatory Affairs to ensure product compliance, support submissions, and maintain conformity with post-market requirements.

EDUCATION AND PROFESSIONAL QUALIFICATIONS:

• 7+ years of experience in project management within the medical device, high-tech, or advanced manufacturing sectors.
• Sc. in Engineering, Life Sciences, or a related technical discipline.
• Proven experience managing high volume consumable or single-use medical-device products.
• Strong understanding of ISO 13485, FDA QSR / 21 CFR Part 820, EU MDR (2017/745) and other relevant regulatory frameworks.
• Strong proficiency in project management tools and methodologies.

ADDITIONAL STRENGTHS:

• Experience with Critical Chain Project Management.
• Project Management Professional (PMP) Designation.
• Demonstrated ability to lead cross-functional teams and drive accountability in a matrixed environment.
• Excellent communication and stakeholder management skills.
• Experience in Product development, electronics, embedded systems, mechanical design,
• and systems integration.
• Experience with measurement systems; optical or magnetic tracking systems and/or machine vision.

THE BENEFITS OF JOINING OUR TEAM

• Competitive pay with a 4% RRSP match to help you plan for the future.
• A comprehensive benefits package that supports your health and well-being.
• Company-wide bonus program and regular salary reviews.
• Employee Stock Purchase Plan offering discounted company shares to help you invest in and benefit from our growth.
• A 37.5-hour work week with a hybrid work model available where responsibilities allow.
• Receive 15 vacation days starting on day one, plus a paid holiday shutdown in December to recharge before the New Year!
• A calendar full of employee social events and engagement activities to keep us connected.
• Professional and personal development support designed to foster your continuous growth and career advancement.
• Work where your contributions are valued — as a multi-year winner of Waterloo Region’s Top Employers and the 2025 Chamber of Commerce Business of the Year, we’re recognized for putting people first and fostering a culture of collaboration and excellence.
• Part of a growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Conveniently located near GRT and ION transit stops, with free on-site parking available.

If you’re looking to join a collaborative and curious team—guided by integrity, bold thinking, and a commitment to doing things right—this could be the team for you. We believe in supporting one another and working together to find creative solutions. You’ll be surrounded by people who are passionate about what they do and driven by work that truly makes a difference. If this sounds like the right fit for you, we invite you to apply online and introduce yourself.

We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. We do not use artificial intelligence or automated decision-making tools in our recruitment process. All applications are reviewed by our hiring team. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.