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Added 10 mins ago
WI
Senior Project Manager - Mining Consulting (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
Innovate and Lead - In this role, you will be at the forefront of innovation, collaborating on transformative projects that push the boundaries of what is possible. If you are looking for a…
Added 10 mins ago
WI
Senior Mechanical Engineer, Material Handling (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
Lead the design and technical evaluation of material handling systems, including conveyors, feeders, crushers, bins, hoppers, chutes, stackers, reclaimers, and related equipment.
Added 10 mins ago
WI
Senior Electrical Engineer (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
As a Senior Electrical Engineer based in Sudbury, Ontario, you will lead electrical engineering for complex mining and industrial projects while helping grow WSP’s local electrical…
Added 10 mins ago
WI
Senior Structural Engineer (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
…heavy industrial projects across Northern Ontario. You will lead complex design, guide multidisciplinary decisions, mentor developing professionals, and help establish the technical…
Added 10 mins ago
CC
Foreman
Copperstone Construction
Halifax, NS
- Full-time
Previous experience as a Foreman, Lead Hand, or similar role in construction is preferred.
Added 10 mins ago
RI
Senior Clinical IAM & RBAC Business Analyst - Healthcare
Rose International
Fredericton, NB
- Full-time
Added 10 mins ago
A
Controls Engineer
Actalent
Surrey, BC
- $50 to $62 CAD / hour
- Contract
Support and lead Factory Acceptance Testing (FAT) prior to equipment deployment.
Added 10 mins ago
A
Manufacturing Engineer
Actalent
Vancouver, BC
- $50 to $57 CAD / hour
- Full-time
Interest in progressing from a technical lead position into a formal management role as the team grows.
Added 10 mins ago
VA
Head of Business Development & Partnerships
Veeda AI
Toronto, ON
- Full-time
You will turn Veeda's technology lead into revenue, building our first commercial engine from the ground up. As a head of Business Development, you own how we go to market: which segments…
Added 10 mins ago
A
Lead Process Engineer
Ausenco
Burlington, ON
- Full-time
We’re seeking a LEAD PROCESS ENGINEER to support our Industrial & Infrastructure team. In this role, you will provide technical leadership throughout the project lifecycle, from conceptual…
Added 10 mins ago
A
Sr Mechanical Design Engineer
Actalent
Cambridge, ON
- $45 to $65 CAD / hour
- Contract
Collaborate with in-house technical and engineering staff to resolve design challenges and integrate systems effectively.
Added 10 mins ago
BB
Senior Technician - Security
Bosch Building Technologies North America
AB · Edmonton, AB
- Full-time
Lead projects at the site level while providing mentorship and technical guidance to junior technicians in testing, troubleshooting, fine-tuning, and optimizing systems for peak operational…
Added 26 mins ago
Manager, Indigenous Relations
British Columbia Lottery Corporation
BC · Hybrid - Kamloops or Vancouver, BC
Added 26 mins ago
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Staff Software Architect - Ground Control Software
MDA
Brampton, ON
- Full-time
Lead requirements, architecture, and design reviews, and provide technical oversight throughout implementation and integration.
Added 26 mins ago
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Toronto, ON · Montreal, QC
- Full-time
Added 40 mins ago
NE
Sales Operations Analyst
Nexus Energy
Toronto, ON
- Contract
…challenges. This role offers the opportunity to strengthen your technical skills, improve processes, and contribute directly to the growth of our renewable energy…
Added 40 mins ago
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Direct Support Worker – Warming Centre
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Prince Albert, SK
- Part-time
Work with Team Lead to provide client information that helps develop case plans, communicate effectively with clients so that they are aware of the supports, resources and rules that are…
Added 40 mins ago
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Team Lead Warming Center– Direct Support Worker
The Salvation Army in Canada
Prince Albert, SK
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Added 40 mins ago
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Generative AI Lead
Terribly Wonderful
Toronto, ON
- Full-time
We are seeking an exceptional Generative AI Lead to help shape the visual development and AI-assisted creative workflows for a feature animated film. This role will serve as both a creative…
Added 56 mins ago
GC
Coordinator, Materials
Glencore Canada
Elkford, BC
- Full-time
Reporting to the Senior lead, Maintenance , the Coordinator, Materials is responsible for the coordination of materials and tooling to support the successful execution of all scheduled and…
Added 56 mins ago
W
Senior Structural Engineer (Sudbury)
WSP
Mississauga, ON
- Full-time
…heavy industrial projects across Northern Ontario. You will lead complex design, guide multidisciplinary decisions, mentor developing professionals, and help establish the technical…
Added 56 mins ago
W
Senior Project Manager - Mining Consulting (Sudbury)
WSP
Fredericton, NB
- Full-time
Innovate and Lead - In this role, you will be at the forefront of innovation, collaborating on transformative projects that push the boundaries of what is possible. If you are looking for a…
Added 56 mins ago
SCM Category Manager, Rotating, Process & E&I Equipment, Pacific Link
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Calgary, AB
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Added 1 hour ago
LH
SENIOR MICROSOFT SYSTEMS ADMINISTRATOR
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ON · Ontario, Canada
- $110,000 to $160,000 CAD / year
- Full-time
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Added 1 hour ago
BC
Registered Practical Nurse - Pre-Admission
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Brantford, ON
- Full-time
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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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