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Added 28 mins ago
MC
Director, FinOps (35690)
Myticas Consulting
BC · British Columbia, Canada
- Full-time
We are seeking an experienced Director, FinOps (Cloud Financial Management) to build, lead, and mature an enterprise FinOps program focused on delivering measurable and sustainable cloud…
Added 28 mins ago
U
Directeur principal, Ingénierie logicielle – WFM / Sr Dir. Software Development - WFM
UKG
Montreal, QC
- Full-time
Added 44 mins ago
CP
Project Coordinator, Construction
Crown Property Management Inc.
Toronto, ON
- $60,000 to $70,000 CAD / year
- Full-time
…tenant construction and/or repair requests as assigned by the Director, Construction to ensure smooth and efficient operation in accordance with internal and external stakeholder…
Added 59 mins ago
UO
Co-op Coordinator
University of Victoria
Victoria, BC
- Full-time
Reporting to the Associate Director, and working closely with all programs in relevant faculties and departments, the Co-op Coordinator will support the strategic direction and promote the…
Added 59 mins ago
BT
Senior Director, Technical Development Lead, Device
BlueRock Therapeutics
Toronto, ON
- Full-time
Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to…
Added 59 mins ago
BT
Director, Supply Chain
BlueRock Therapeutics
Toronto, ON
- Full-time
Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to…
Added 1 hour ago
C
Senior Manager, Safety Management System & Safety Culture
CAE
Montreal, QC
- Full-time
Advise the Director Global Safety on SMS strategy, system maturity, emerging industry practices, and safety governance improvements.
Added 1 hour ago
RB
Senior Director, Data Architecture & Engineering
Royal Bank of Canada
Toronto, ON
- Full-time
The Senior Director, Data Architecture simplifies and unifies RBC's data architecture across the full lifecycle: manufacturing, distribution, discovery, consumption and governance. They own…
Added 1 hour ago
EI
Preconstruction PM - ICI Projects
EBC Inc.
Mississauga, ON
- Full-time
…process while working closely with the Preconstruction/Bid Director. The successful candidate will have demonstrated experience delivering large-scale P3 and Design-Build (DB) projects and…
Added 1 hour ago
FB
Project Director - Major Projects
Forbes Bros. Group of Companies
Saskatoon, SK
- Full-time
Forbes Bros. Group of Companies is seeking an experienced Project Director to lead the successful delivery of complex, high-value utility infrastructure projects across North America. In…
Added 1 hour ago
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Project Director - Major Projects
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Toronto, ON
- Full-time
Forbes Bros. Group of Companies is seeking an experienced Project Director to lead the successful delivery of complex, high-value utility infrastructure projects across North America. In…
Added 1 hour ago
B
Client Director
BGIS
Montreal, QC
- Full-time
The Client Director is accountable for program management and delivery, project delivery, client relationship management, and people leadership.
Added 1 hour ago
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Project Director - Major Projects
Forbes Bros. Group of Companies
Ottawa, ON
- Full-time
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Added 1 hour ago
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Project Director - Major Projects
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Winnipeg, MB
- Full-time
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Project Director - Major Projects
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Calgary, AB
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Global Methods Engineer - Machining
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Mirabel, QC
- Full-time
Within the manufacturing engineering team, the main missions are to:
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Project Manager (Mining)
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Montreal, QC
- Full-time
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Added 1 hour ago
UO
Energy Conservation Engineer
University of British Columbia
Vancouver, BC · UBCV | Campus Energy Centre (CEC)
- $9,599.75 to $14,385.5 CAD / month
- Full-time
- Conducting peer reviews of energy system design, engineering drawings, specifications and other technical work completed by external contractors;
Added 2 hours ago
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Project Manager
HRbrain Inc.
Montreal, QC
- Contract
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Added 2 hours ago
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Purchasing Manager
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Cornwall, ON
- Full-time
This is a hands-on purchasing role that involves working closely with our Production Department, particularly the Director of Production, to support manufacturing schedules and material…
Added 2 hours ago
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Resident Care Attendant - AgeCare Mount Ida Mews
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The Resident Care Attendant reporting to the Director of Care and/or Resident Care Manager ensures and supports the collaboration and evaluation of the resident care services in accordance…
Added 2 hours ago
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Manager, Product Strategy & Operations
eBay
Toronto, ON
- Full-time
…to automate and improve operations. You will report to the Director of Product Strategy and Operations and collaborate with product leads, engineering, Finance, and program and product…
Added 2 hours ago
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Bell
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The Director of Engineering is responsible for the strategic leadership, technical direction, operational performance, and ongoing evolution of Dome Productions' engineering organization.…
Added 2 hours ago
UO
Director, Research Infrastructure
University of Saskatchewan
Saskatoon, SK
- Full-time
The director, research infrastructure provides strategic leadership and operational oversight for research infrastructure across the university. This position leads the planning,…
Added 2 hours ago
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Digital Sales Engineer / Market Development Manager-Automation-Flygt
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BlueRock Therapeutics

Senior Director, Technical Development Lead, Device

Toronto, ON, Canada

Full-time

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Job details

Job type: Full-time
Experience: 12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
Posting language: English
Posted: Jul 14, 2026

Original job description

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines. Utilizing our proprietary CELL+GENE™ platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological diseases.

Founded in 2016, BlueRock is at the forefront of the convergence of cell biology and genetic engineering. Our mission is to harness pluripotent stem cell technology and gene editing to deliver authentic, functional cell therapies that address the root causes of disease and offer hope to millions of patients worldwide.

What Are We Doing?

Our foundational science enables the generation and directed differentiation of universal pluripotent stem cells into authentic, functional cells for allogeneic cellular therapies.

We are passionate about realizing the promise of cell and gene therapy, shaping the future of regenerative medicine, and delivering new therapies to patients with limited or no treatment options.

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy company harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Description of Position:

This role is responsible for providing strategic and technical leadership for the development and execution of potential delivery device systems supporting the company’s combination cell therapy portfolio. In addition, this role serves as the single point of accountability for program-level technical development, ensuring alignment from early development through clinical stages and commercialization readiness. The individual will bring deep expertise in medical device development and commercialization, integrated with biologics/cell therapy development, to enable successful delivery of complex combination products.

This leader will work cross‑functionally with Device Development, Clinical Development, Regulatory Affairs, Quality, and External Manufacturing teams to ensure device solutions are robust, scalable, regulatory‑compliant, and aligned with patient, clinician, and business needs.

Responsibilities:

Strategy & Leadership

Define and lead the medical device development strategy aligned with the company’s cell therapy pipeline and long‑term platform vision.

Act as a core leader for combination product development, ensuring strategic alignment across various technical areas.

Serve as the primary technical leader in governance forums.

Act as a thought leader in device‑enabled cell therapy delivery, monitoring emerging technologies, standards, and competitive approaches.

Produce Development Oversight

Lead integration of device options into an overall program strategy

In partnership with functional leadership, oversee device development activities including but not restricted to: user needs, design inputs/outputs, risk management, verification & validation, and design transfer

Ensure device designs are compatible with sterile, GMP, and scalable manufacturing environments while meeting international or region-specific standards.

Program Leadership

Drive integrated development plans and timelines ensuring execution across a matrixed organization

Partner with Regulatory Affairs to define and execute U.S. and global regulatory strategies for combination products (e.g., FDA CDRH/CBER interactions).

Support regulatory submissions including IND‑enabling device sections, IDEs, 510(k), PMA, De Novo, and combination product filings as applicable.

Partner with various stakeholders to ensure devices meet real‑world clinical workflows and adoption requirements

Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and applicable combination product regulations.

Minimum Requirements:

Advanced degree (MS, Ph.D., or equivalent) in Biomedical Engineering, Mechanical Engineering, Materials Science, or related discipline.
12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
Demonstrated success leading complex device programs from concept through commercialization.
Hands‑on experience with combination products, drug‑device or biologic‑device integrations strongly preferred.
Deep knowledge of medical device regulatory frameworks and design control requirements.
Track record of building and leading high‑impact technical teams.
Experience managing external development partners, CDMOs, and device vendors.
Strategic thinker with strong execution discipline
Collaborative, strategic leader who thrives in cross‑functional matrix organizations
Clear communicator with the ability to influence at executive and board levels

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.



The estimated compensation range for this position is $ 230,000.00 - $ 243,630.00 per year.

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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More about this job

Responsibilities

Lead the strategy and technical development of delivery devices for cell therapy combination products, overseeing design, risk management, verification, validation, and manufacturing readiness. Drive integrated program plans and regulatory strategies while coordinating cross-functional teams and external partners through clinical development and commercialization readiness.

Requirements

Requires an advanced degree in biomedical engineering, mechanical engineering, materials science, or a related discipline, plus at least 12 years of progressive medical device development experience and senior leadership experience. Candidates should have a record of leading complex programs through commercialization, strong knowledge of device regulations and design controls, and experience with combination products, teams, and external development partners.

Skills

Medical Device Development
Cell Therapy
Device Strategy
Program Leadership
Design Controls
Risk Management
Verification And Validation
Regulatory Strategy
FDA Regulatory Affairs
GMP Manufacturing
ISO 13485
ISO 14971
21 CFR Part 820
Cross-Functional Leadership
External Partner Management

Visa sponsorship

Not detected in the job text

Keywords

Medical Device Development
Combination Products
Cell Therapy
Biologics
Drug-Device Integration
Biologic-Device Integration
Device Development Strategy
Design Inputs And Outputs
Design Controls
Risk Management
Verification And Validation
Design Transfer
Sterile Manufacturing
GMP
Scalable Manufacturing
FDA CDRH
FDA CBER
IND
IDE
510(k)
PMA
De Novo
ISO 13485
ISO 14971
21 CFR Part 820
Regulatory Affairs
Clinical Workflows
Program Management
CDMOs
External Development Partners

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