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Added 7 mins ago
ST
Value Optimization Engineer
SEGULA Technologies
Windsor, ON
- Contract
Experience in automotive engineering, value engineering, cost optimization, design release, benchmarking, or product development.
Added 21 mins ago
CC
Bilingual Technical Pre-Sales Consultant-Hybrid
Canon Canada
Quebec, QC
- $71,300 to $82,000 CAD / year
- Full-time
…centers on conducting deep-dive discovery and needs analysis to engineer scalable, high-impact solution architectures that optimize document…
Added 22 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 22 mins ago
MC
Technical Consultant III (35732)
Myticas Consulting
Toronto, ON
- Full-time
Technical Consultant III (Software Engineer, Senior/Lead)
Added 22 mins ago
V
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 22 mins ago
1
Product Builder / Senior Product Engineer - AI Products
15Rock
Toronto, ON
- Full-time
The Product Builder owns a product problem from the first client conversation to working software in the client's hands. You find the problem worth solving, decide what to build, and build…
Added 53 mins ago
BT
Senior Director, Technical Development Lead, Device
BlueRock Therapeutics
Toronto, ON
- Full-time
Act as a core leader for combination product development, ensuring strategic alignment across various technical areas.
Added 53 mins ago
BT
Director, Supply Chain
BlueRock Therapeutics
Toronto, ON
- Full-time
…chain strategy and operations in support of research, process development, clinical manufacturing, and clinical trial execution. As a key member of the Cell Therapy Product Supply…
Added 1 hour ago
T
Quality Engineer I
TD
Toronto, ON
- Full-time
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 1 hour ago
M365 Architect
EY
Toronto, ON
…team helping to develop and plan our strategy, support the development of our capabilities and operationalizing our offerings. In this role, you will also participate in key opportunities…
Added 1 hour ago
C
Senior Advisor, Product Line Management, Maintenance & Managed Services
Ciena
Canada
- Full-time
…guided by innovation, integrity, and collaboration. Through development opportunities, meaningful work, and flexibility, Ciena supports growth and well-being - on and off the job. Connect…
Added 1 hour ago
FA
Vice President, Quality Control
FTAI Aviation
Montreal, QC
- Full-time
…Organization (AMO). This leader owns the airworthiness of every product released by the AMO and is accountable to the Head of FTAI Canada (Accountable Executive) for ensuring that all…
Added 1 hour ago
X
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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Global Methods Engineer - Machining
Safran
Mirabel, QC
- Full-time
Manage product/reference/process evolutions as well as the development of new products.
Added 1 hour ago
P
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
WW
Electronic Hardware Developer II
Watts Water Technologies
Vernon, BC · Tekmar Control Systems
- Full-time
This solutions focused and hands on junior engineer/technologist, as part of the tekmar hardware engineering team will be responsible for working on a range of electronic hardware…
Added 1 hour ago
T
Engineer I
TD
Mississauga, ON · Toronto, ON
- Full-time
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 2 hours ago
HT
Manufacturing Engineer (Contract)
Husky Technologies
Bolton, ON
- Full-time
Husky TechnologiesTM offers a wealth of opportunity for personal growth and development. Most importantly, Husky Technologies TM offers an opportunity to work with – and be challenged by –…
Added 2 hours ago
T
Engineer I
TD
Toronto, ON
- Full-time
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 2 hours ago
IT Engineer, Google Workspace
HelloFresh
Toronto, ON
Strong Collaboration: Ability to work effectively with cross-functional teams, including developers, product managers, and other IT personnel.
Added 2 hours ago
RV
Principal FPGA & Hardware Developer
Ross Video
Ottawa, ON · Nepean, ON
- Full-time
System thinker: Connects FPGA logic, embedded software, PCB design, power, clocks, resets, SI/PI, thermals, manufacturing, and product behavior.
Added 2 hours ago
MC
Senior QA Engineer III – Automation | Banking | API | Kafka | ETL (35729)
Myticas Consulting
Ottawa, ON
- Full-time
Senior QA Engineer III – Automation | Banking | API | Kafka | ETL
Added 2 hours ago
MC
Network Engineer (35135)
Myticas Consulting
Ottawa, ON
- Full-time
The Network Service Engineer will work closely with Commercial, Product, Sales Engineering, Customers, Network Engineering, and external contractor teams to provide technical guidance on…
Added 2 hours ago
MC
Senior Mechanical PCB Engineering Consultant (35428)
Myticas Consulting
Ottawa, ON · Kanata, ON
- Contract
Seeking an experienced Mechanical Engineer to provide onsite engineering support for the development of advanced hardware platforms and optical communication products. The consultant will…
Added 2 hours ago
BP
Senior Java Developer
BNP Paribas
Montreal, QC
- Full-time
Prime Services Technology is seeking a Senior Java Engineer in Montreal to design and deliver reliable, scalable distributed systems. This is a hands-on senior individual contributor 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

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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