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Added 11 mins ago
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Principal Structural Designer
Worley
Calgary, AB · Edmonton, AB
- Full-time
We are currently recruiting for a Principal Structural Designer. Our team includes world class experts and dynamic go-getters. This is a full-time position based in Calgary, Alberta.
Added 11 mins ago
NT
Manager Security Assurance
NZ Transport Agency Waka Kotahi
Hamilton, ON
- Full-time
Lead NZTA's independent security assurance function and a team of five
Added 11 mins ago
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Refrigeration Operating Engineer
Americold
Dartmouth, NS
- Full-time
…accessible. With 240+ facilities across four continents and 14,000+ team members, we’re a global leader in temperature-controlled logistics. Our mission is to help our customers feed the…
Added 25 mins ago
OB
Sales Manager
Olympic Building Centre
Winnipeg, MB
- Full-time
Leads and manages the Building Consultants team (sales representatives) to achieve sales goals
Added 25 mins ago
QC - ASSISTANT STORE MANAGER
The Aldo Group Inc / Le Groupe Aldo Inc.
Montreal, QC
…amazing store experience. You lead by example, inspire your team to hit sales goals, and make every customer feel their best walking out the…
Added 41 mins ago
EI
Test Specialist - CDU
Ecolab Inc.
Calgary, AB
- Full-time
Join CoolIT, an Ecolab Company, a global leader in Direct Liquid Cooling technology for data centers, supercomputers, and high-performance computing environments.
Added 41 mins ago
EI
Mechanical Designer
Ecolab Inc.
Calgary, AB
- Full-time
Join CoolIT, an Ecolab Company, a global leader in Direct Liquid Cooling technology for data centers, supercomputers, and high-performance computing environments.
Added 41 mins ago
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Maintenance Technician
CBRE HV
Toronto, ON
- Full-time
Impact team through defined duties, methods and tasks as described in detail.
Added 56 mins ago
PH
Social Worker - Medicine (NSPH)
Providence Health Care
Vancouver, BC
- Full-time
Reporting to the designated Social Work Site Leader and receiving guidance and support from the Professional Practice Leader and/or Research, Education and Practice Coordinator, the…
Added 56 mins ago
SC
Accounting Manager
Sound CPA
Owen Sound, ON
- Full-time
Develop as a leader. Expand your experience in team management, client advisory, and practice operations.
Added 56 mins ago
AU
Customer Service Coordinator
Alsco Uniforms
Surrey, BC
- $20.26 CAD / hour
- Full-time
We are seeking a friendly, organized, and proactive Customer Service Coordinator (CSC) to join our Service team. In this role, you will be the first point of contact for our customers,…
Added 56 mins ago
TA
General Manager
Third Avenue Spa
Ottawa, ON
- Full-time
Our success is rooted in personalized care, lasting client relationships, and a dedicated team of professionals who take pride in their work.
Added 56 mins ago
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Director, Governance, Risk & Compliance (GRC)
Robertson & Company Ltd.
Toronto, ON
- Full-time
Our client, a leader in the industry, is seeking a dedicated Director of Governance, Risk, and Compliance to join their team. In this role, you will lead efforts to develop and implement…
Added 56 mins ago
GM
Service plumber/ boiler technician
Gateway Mechanical Services
Calgary, AB
- Full-time
Ability to deliver responsive, respectful customer service and communicate clearly with clients and team members.
Added 1 hour ago
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Lead Building Services Design Engineer
Fluor
Vancouver, BC
- Full-time
Fluor is one of Canada's top employers and is recognized globally as a leader in the Engineering, Procurement, Construction, Fabrication, and Maintenance industry. Our focus on innovation…
Added 1 hour ago
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Principal Designer- Material Handling
Fluor
Calgary, AB
- Full-time
…Handling role in its Calgary location. Virta is an industry leader in high performance material handling equipment with a focus on design, supply and project execution. Virta is a globally…
Added 1 hour ago
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Supervisor, Material Management
Fluor
Vancouver, BC
- Full-time
Fluor is one of Canada's top employers and is recognized globally as a leader in the Engineering, Procurement, Construction, Fabrication, and Maintenance industry. Our focus on innovation…
Added 1 hour ago
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Project Controls Specialist III
Fluor
Vancouver, BC
- Full-time
…activities for a project or assignment. This role serves as Control Team Leader on small projects and provides direct supervision to a small team of Project Controls personnel, or as a…
Added 1 hour ago
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Principal Designer - Senior Bulk Material Handling
Fluor
Vancouver, BC
- Full-time
Fluor is one of Canada's top employers and is recognized globally as a leader in the Engineering, Procurement, Construction, Fabrication, and Maintenance industry. Our focus on innovation…
Added 1 hour ago
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Principal Process Engineer - Power Projects
Fluor
Calgary, AB
- Full-time
Fluor is one of Canada's top employers and is recognized globally as a leader in the Engineering, Procurement, Construction, Fabrication, and Maintenance industry. Our focus on innovation…
Added 1 hour ago
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Directeur principal, Ingénierie logicielle – WFM / Sr Dir. Software Development - WFM
UKG
Montreal, QC
- Full-time
Servir de leader d’opinion influent qui promeut l’innovation, communique la vision et contribue à la WFM et à la stratégie technologique plus large.
Added 1 hour ago
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store manager, Campbell River, B.C
Starbucks Coffee Company
Campbell River, BC
- $62,500 to $82,600 CAD / year
- Full-time
…(employees), customers and communities – globally. As a Starbucks leader you are driven by a deep sense of purpose. You are aspirational - never a bystander. You take action to make a…
Added 1 hour ago
CI
Seasonal Associate
Carters Inc.
Calgary, AB
- Part-time
…most-purchased children’s clothing brand.* We’ve become an industry leader by providing quality - from the first Original Bodysuit® to the lasting careers we offer our team. We’ve kept our…
Added 1 hour ago
BS
R&D Product Development Intern / Stagiaire en recherche et développement (R-D) - Développement de
Boston Scientific
Montreal, QC
- Full-time
Experience with engineering design or product development activities through co-op, internship, research, capstone, or student design team projects.
Added 1 hour ago
CI
Seasonal Associate
Carters Inc.
Calgary, AB
- Part-time
…most-purchased children’s clothing brand.* We’ve become an industry leader by providing quality - from the first Original Bodysuit® to the lasting careers we offer our team. We’ve kept our…

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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