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Added 8 mins ago
ST
Value Optimization Engineer
SEGULA Technologies
Windsor, ON
- Contract
SEGULA Technologies Canada is looking for a Value Optimization Engineer to support automotive engineering programs and identify innovative cost, weight, complexity, and value optimization…
Added 8 mins ago
AI
Senior Level 3 AI Engineer – Copilot, ChatGPT, Grok, Claude & Gemini
Astra-North Infoteck Inc. ~ Conquering today’s challenges, achieving tomorrow’s vision!
Montreal, QC
- Full-time
We are seeking a Senior Level 3 AI Engineer to act as the first point of call for engineering issues across end user AI products - Microsoft Copilot, OpenAI ChatGPT, Anthropic Claude, Grok…
Added 8 mins ago
V
Engineer - Ground Control
Vale
Sudbury, ON · Greater Sudbury, ON,CA
- Full-time
…Japan, VBM delivers a secure and responsible supply of high-quality products to customers across Europe, the Americas, and…
Added 23 mins ago
B
Senior Databricks Data Platform Engineer
Brillio
Canada
- Contract
As a Senior Databricks Data Platform Engineer, you will own the engineering, automation, and day-to-day health of our enterprise Databricks Lakehouse platform. This is a platform-first…
Added 23 mins ago
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Technical Consultant III (35732)
Myticas Consulting
Toronto, ON
- Full-time
Technical Consultant III (Software Engineer, Senior/Lead)
Added 23 mins ago
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Architect
Virtusa
Toronto, ON
- Full-time
Job Summary: We are seeking a Senior QA Automation Engineer who plays a critical role in upholding the quality standards of our software delivery lifecycle. This position is responsible for…
Added 23 mins ago
EG
Senior Municipal Engineer
Egis Group
Calgary, AB · Toronto, Ontario
- $130,000 to $170,000 CAD / year
- Full-time
Senior Municipal Engineer responsible for leading roadway and municipal infrastructure design initiatives within Canada. The role sits within a municipal engineering team supporting…
Added 54 mins ago
BT
Senior Director, Technical Development Lead, Device
BlueRock Therapeutics
Toronto, ON
- Full-time
…platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological…
Added 54 mins ago
BT
Director, Supply Chain
BlueRock Therapeutics
Toronto, ON
- Full-time
…platform, we direct cellular differentiation and genetically engineer cells to create transformative therapies for patients suffering from neurological and ophthalmological…
Added 1 hour ago
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Quality Engineer I
TD
Toronto, ON
- Full-time
Design, build, execute, and maintain manual/automated tests across the SDLC, embedding quality into continuous delivery pipelines.
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Apprentice Engineer (Level 8)
targetjobs UK
Mayo, YT
- Full-time
Assisting with site operations including surveying, inspections and quality checks
Added 1 hour ago
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Senior Municipal Engineer
Egis in Canada
Calgary, AB
- $130,000 to $170,000 CAD / year
- Full-time
Senior Municipal Engineer responsible for leading roadway and municipal infrastructure design initiatives within Canada. The role sits within a municipal engineering team supporting…
Added 1 hour ago
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Senior Advisor, Product Line Management, Maintenance & Managed Services
Ciena
Canada
- Full-time
Serve as the expert portfolio advisor for complex maintenance, managed-service and resident-engineer opportunities.
Added 1 hour ago
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Data Engineer - Snowflake, dbtCore/Cloud, AWS
Aviva Canada
Markham, ON
- Full-time
Aviva Canada is looking for a Data Engineer to support our enterprise data modernization journey. You’ll use your expertise across modern and legacy platforms to build robust data pipelines…
Added 1 hour ago
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Vice President, Quality Control
FTAI Aviation
Montreal, QC
- Full-time
The Vice President, Quality Control is the Person Responsible for Maintenance (PRM) for FTAIC's Transport Canada Approved Maintenance Organization (AMO). This leader owns the airworthiness…
Added 1 hour ago
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Senior Geotechnical Applications Engineer
Xerxes
AB · Edmonton, AB
- Full-time
As a Senior Geotechnical Applications Engineer with Xerxes, you will be a key technical resource supporting the application, installation, and field performance of underground storage tank…
Added 1 hour ago
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Senior Piping Engineer
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Calgary, AB
- Full-time
We’re looking for a Senior Piping Engineer who brings exceptional technical knowledge, leadership, and a passion for designing safe, efficient, and reliable piping systems. In this role,…
Added 1 hour ago
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Full Stack Engineer, Storefront
Pepper
Remote, Canada
- $149,000 to $164,000 CAD / year
- Full-time
- Remote
As an engineer on the Storefront team, you'll work on Pepper's flagship product: the e-commerce system distributors run their business on and their customers order through every day. Tens…
Added 1 hour ago
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Co-op Student - Construction (Winter 2027)
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Toronto, ON
- Full-time
The East Harbour Transit Hub Alliance is in search of a Coop Student (Quality) in Toronto. The Coop Student (Quality) role will be part of a high-performing project team that is dedicated…
Added 1 hour ago
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Mechanical Engineer - SABRE (Permanent)
Orano Canada
SK · Saskatchewan, Canada
- Full-time
Assist in managing project delivery, including costs, schedules, quality, tracking, and reporting key performance indicators (KPIs)
Added 1 hour ago
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Mechanical Engineer - SABRE
Orano Canada
SK · Saskatchewan, Canada
- $118,350 to $139,200 CAD / year
- Full-time
Assist in managing project delivery, including costs, schedules, quality, tracking, and reporting key performance indicators (KPIs)
Added 1 hour ago
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Project Engineer
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Blainville, QC
- Full-time
…custom parts. They rely on the expertise of their team, the quality of their work, and the reliability of their execution to meet the demanding needs of their industrial clients. Your Role…
Added 1 hour ago
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Senior Civil Engineer- Water
Stantec
Burnaby, BC
- Full-time
The role of the Senior Civil Engineer is to work on complex and exciting projects both independently and as a team member. In this position you could work as a technical engineer, project…
Added 1 hour ago
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Senior Electrical Engineer- Water
Stantec
Calgary, AB
- Full-time
We are currently seeking a passionate Senior Electrical Engineer to join our project delivery team: The same team that is tasked with delivering some of the most interesting and iconic…
Added 1 hour ago
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Electronic Hardware Developer II
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…water solutions for the future. Watts is a leading brand with a quality reputation - and we have a dynamic future…

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

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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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