Director, Research & Development

Baylis Medical Technologies Inc.; Mississauga; Hybrid; CAD 180,000 - 240,000; Full time

Job summary

Baylis Medical Technologies Inc. is seeking a Director, Research & Development to lead Advanced Development, New Product Development and Sustaining Engineering under one vision and operating model.

You will drive portfolio strategy, resource allocation and capability building, mentoring managers and senior engineers while ensuring regulatory readiness and design control excellence to deliver innovative medical devices.

Qualifications

• 10+ years in progressive product development with medical devices.
• Experience leading through managers and cross-functional teams.
• Proven ability to translate technology into product strategy and roadmaps.
• Knowledge of ISO 13485 and regulatory requirements.
• Experience in Advanced Development and New Product Development.
• Strong design controls, risk management, and quality systems.
• Willingness to travel up to 25%.

Responsibilities

• Provide strategic and operational leadership for the R&D organization.
• Drive process quality and design control excellence, ensuring compliant documentation.
• Own delivery of the R&D portfolio with clear technical direction and plans.
• Identify and develop future technical capabilities and platforms.
• Lead through managers and senior technical leaders across engineering.
• Collaborate with Commercial, Medical Affairs, Quality, Regulatory, Operations, PMO.
• Ensure alignment with business objectives and regulatory requirements.

Skills

Leadership

R&D management

Medical device industry

Design controls

Regulatory knowledge

Cross-functional collaboration

Strategic thinking

Communication

Travel readiness

Portfolio management

Education

Bachelor’s degree in Engineering

Advanced degree

P.Eng. designation (asset)

Job description

At Baylis Medical Technologies, we are dedicated to developing innovative medical devices that enhance patient care and improve lives. Our Research & Development team is at the forefront of designing, testing, and commercializing groundbreaking technologies for minimally invasive endovascular procedures. As the Director, Research & Development you will lead the company’s product development function, including Advanced Development, New Product Development and Sustaining Engineering. The role unifies product development under one vision and operating model and is accountable for portfolio strategy, resource allocation, organizational capability, and the predictable delivery of innovative medical devices that meet customer, clinical, regulatory, quality and business requirements.

Impact Through Innovation

• Provide strategic and operational leadership for the R&D organization, including Advanced Development, New Product Development and Sustaining Engineering, under one vision and operating model.
• Drive process, quality and design control excellence, ensuring compliance and the completeness and technical accuracy of design documentation, including the Design History File.
• Own the predictable delivery of the R&D portfolio, ensuring programs have clear technical direction, realistic plans, disciplined decision-making and timely escalation of risks and trade-offs.
• Identify and develop future technical capabilities, technologies and innovation platforms that strengthen the company’s competitive position and support long-term growth.
• Lead through managers and senior technical leaders, building leadership capability, accountability and ownership and a culture of technical excellence across the R&D organization.
• Monitor competitive developments, emerging technologies and external innovation opportunities to inform product and technology strategy.
• Lead Advanced Development activities to evaluate new technologies, product concepts and growth opportunities, progressing ideas from concept and feasibility into product development.
• Improve project execution, delivery predictability and cost effectiveness through effective governance, disciplined processes, technical standards and continuous improvement.
• Develop and execute the R&D portfolio strategy, making prioritization, resource allocation and investment decisions across multiple Advanced Development, New Product Development and Sustaining Engineering initiatives.
• Partner effectively with Commercial, Medical Affairs, Quality, Regulatory Affairs, Operations, Supply Chain, Finance and the PMO to align priorities and advance company objectives.

Required Skills:

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering or a related technical discipline.
• 10+ years of progressive product development experience, including significant leadership experience in the medical device industry. Candidates from other highly regulated physical-product industries may be considered where they have directly relevant design-control, risk-management and commercialization experience.
• Demonstrated experience leading through managers, senior technical leaders and multidisciplinary engineering teams, with a strong track record of developing talent, building leadership capability and strengthening organizational performance.
• Experience leading R&D within a growth-oriented or entrepreneurial
• Proven experience taking medical devices from early-stage research, feasibility and Advanced Development through product development, design verification and validation, and commercialization.
• Demonstrated experience developing R&D strategy and leading multiple product development programs or portfolios, including making prioritization, resource allocation and investment decisions aligned with business objectives.
• Strong knowledge of medical device design controls, risk management and quality systems, including ISO 13485 and applicable Canadian, U.S. and European regulatory requirements.
• Demonstrated ability to improve project execution, predictability, development cost and organizational effectiveness across multiple concurrent programs.
• Strong strategic and business judgment, with the ability to balance technical, clinical, regulatory, commercial, operational and financial considerations and make sound decisions as priorities evolve.
• Strong cross-functional leadership and influence, with an enterprise perspective and the ability to create alignment and accountability across teams with different priorities and lead effectively through organizational or process change.
• Strong executive-level communication skills, with the ability to translate complex technical matters into clear business implications, recommendations and decisions.
• Ability and willingness to travel up to 25% within Canada, the United States and internationally, including the ability to obtain and maintain documentation required for business travel.

Asset Skills:

• Professional Engineer (P.Eng.) designation or eligibility for licensure in Canada is an asset.
• Advanced degree in Engineering, Business Administration or a related field.
• Experience developing and commercializing minimally invasive medical devices, including catheter-based technologies.
• Experience with electromechanical medical device development.
• Experience identifying and developing emerging technologies, innovation platforms or external technology opportunities.

Our Distinctive Edge

• Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
• Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
• Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
• Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
• Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
• Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities – fostering camaraderie and fun.

Our Impact

Baylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.

Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.

Please inform us if you require any accommodation during the recruitment process.

Travel Required

Yes . 25% travel within Canada, US and internationally as required.