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Added 8 mins ago
TT
Senior Oracle DBA
Tech Talent International
Toronto, ON
- $73 to $75 CAD / hour
- Contract
Lead database release automation, code reviews, and schema migrations across Development, Staging, and Production.
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
…complex queries that front-line support cannot resolve, work with lead Microsoft and vendor engineers on new features, and uplift the wider support team. Each engineer maintains broad…
Added 23 mins ago
AI
Senior Database Administrator (Oracle Application DBA / Cloud)
Astra-North Infoteck Inc. ~ Conquering today’s challenges, achieving tomorrow’s vision!
Toronto, ON
- Full-time
Lead database release automation, code reviews, and schema migrations across development, staging, and production environments.
Added 23 mins ago
MC
SAP OTC Service Delivery Manager – Projects & Enhancements (36082)
Myticas Consulting
Toronto, ON
- Contract
The Service Delivery Manager will be an experienced and seasoned SAP OTC lead with strong project and integration management capability. The resource will be responsible for leading small…
Added 23 mins ago
MC
Senior Enterprise Information Data Architect (35902)
Myticas Consulting
Canada
- Contract
Support enterprise Master Data Management (MDM), metadata management, data integration, analytics and information management capabilities.
Added 23 mins ago
U
Directeur principal, Ingénierie logicielle – WFM / Sr Dir. Software Development - WFM
UKG
Montreal, QC
- Full-time
…développement logiciel agentique, les tests automatisés, l’intégration continue et la livraison continue, l’observabilité, le développement sécurisé et la préparation à la…
Added 23 mins ago
B
Senior Databricks Data Platform Engineer
Brillio
Canada
- Contract
…workspaces, account-level settings, networking, and identity…
Added 23 mins ago
MC
Technical Consultant III (35732)
Myticas Consulting
Toronto, ON
- Full-time
You will also lead the deployment of assigned products, modules, configurations, integrations, and technical components across development, QA, integration, UAT, staging, and other lower…
Added 23 mins ago
F
Director of Finance
FORM
Vancouver, BC
- $135,000 to $170,000 CAD / year
- Full-time
Lead a two-person accounting team, managing our Senior Accountant and supporting the development of the Accountant on their team
Added 23 mins ago
A
Principal Visual Experience Designer
Autodesk
Toronto, ON
- Full-time
…delight to complex professional software. In this role, you will lead visual design for key Construction platform initiatives, helping define and align core Forma experiences including…
Added 23 mins ago
IG
Sr. Product Owner
Insight Global
Toronto, ON
- $70 to $75 CAD / hour
- Full-time
Strong knowledge of cloud web services: Handling integration between modern web services and legacy platforms
Added 23 mins ago
RF Developer
Sonova AG
Kitchener, ON
…from early concept development through to successful product integration and…
Added 23 mins ago
RG
SVP, Head of Operational Risk Management
Reinsurance Group of America
Toronto, ON
- Full-time
Lead enterprise-wide risk identification, assessment, monitoring, and reporting processes for operational risk. Ensure integration of operational risk considerations into business…
Added 23 mins ago
EG
Senior Municipal Engineer
Egis Group
Calgary, AB · Toronto, Ontario
- $130,000 to $170,000 CAD / year
- Full-time
…roadways, interchanges, and intersections. Responsibilities include integration of multi-disciplinary inputs such as watermain systems, stormwater and sanitary services, utility…
Added 39 mins ago
IH
Lead | Surgical Service Network
Interior Health Authority
Kelowna, BC
- Full-time
Interior Health is seeking permanent full-time Lead, Surgical Service Network. This exciting opportunity offers the chance to be part of a collegial and productive team that supports system…
Added 39 mins ago
Director Technology Transformation Stores
Sobeys Capital Incorporated or a Franchise/Affiliate / ou une franchise/société affiliée
Stellarton, NS · Mississauga, ON
Build, lead, and develop the dedicated internal technology delivery organization while defining the need for external partners and managing them through delivery
Added 54 mins ago
BT
Senior Director, Technical Development Lead, Device
BlueRock Therapeutics
Toronto, ON
- Full-time
Lead integration of device options into an overall program strategy
Added 1 hour ago
C
Senior Manager, Safety Management System & Safety Culture
CAE
Montreal, QC
- Full-time
The Senior Manager, Safety Management System & Safety Culture serves as CAE's lead for the development, governance, promotion and continual improvement of the Global Safety Management…
Added 1 hour ago
B
BUSINESS ADVISOR, OPERATIONAL EFFICIENCY (Automation) - Calgary
BDC
Calgary, AB
- Full-time
Lead projects from initiation to completion, ensuring scope, budget, timelines, quality standards, and client expectations are met.
Added 1 hour ago
AI
Senior Java- Low Latency Developer
Astra-North Infoteck Inc. ~ Conquering today’s challenges, achieving tomorrow’s vision!
Mississauga, ON
- Full-time
Lead solution design discussions, code reviews, and performance optimization activities.
Added 1 hour ago
EI
Senior Municipal Engineer
Egis in Canada
Calgary, AB
- $130,000 to $170,000 CAD / year
- Full-time
…roadways, interchanges, and intersections. Responsibilities include integration of multi-disciplinary inputs such as watermain systems, stormwater and sanitary services, utility…
Added 1 hour ago
P
Software Engineering Manager Risk Management Platform
PCMI
Canada
- Full-time
We are looking for a Engineering Manager who can lead the modernization of PCMI's Risk Management Platform. This individual will oversee the transfer from legacy monolith architecture into…
Added 1 hour ago
LH
Human Resources Lead, M&A Integration
Lifemark Health Group
Toronto, ON
- $80,000 to $110,000 CAD / year
- Full-time
The Human Resources Lead, M&A Integration is responsible for leading the HR components of acquisitions from due diligence through to post-close integration. This role partners closely with…
Added 1 hour ago
T
Senior Project Manager (Experiential Production)
THE·TEAM
Toronto, ON · Greater Toronto Area, Canada
- Full-time
…while also supporting experiential builds, custom fabrication, integration of Experiential technology & tech, and complex installations depending on the needs of each…
Added 1 hour ago
CM
Search Lead
Critical Mass
Toronto, ON
- Full-time
At Critical Mass, the Search Lead advances account- and practice-level priorities by leading data-driven Search strategy and delivery for a leading financial-services client. The role…

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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