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Added 14 mins ago
V
Engineer - Ground Control
Vale
Sudbury, ON · Greater Sudbury, ON,CA
- Full-time
…to aerospace, batteries to magnets, robotics to artificial intelligence, a secure and responsible supply of critical minerals is fundamental to power modern technologies. And at Vale Base…
Added 28 mins ago
PC
Corporate Finance Senior Associate (Bilingual FR/EN)
PwC Canada
QC · Clarke City, QC
- Full-time
As a Corporate Finance Senior Associate (Bilingual FR/EN) , you’ll work as part of a team of problem solvers, helping to solve business issues, deliver high-quality client service and…
Added 28 mins ago
SS
Account Executive, Commercial Interiors
Summit Search Group
Vancouver, BC · Greater Vancouver, BC
- Full-time
Provide market intelligence, client feedback, and sales updates to senior leadership.
Added 28 mins ago
U
Growth & Marketing Lead
Ultrassure
Toronto, ON
- Full-time
Experience in B2B marketing, growth, partnerships, business development or a customer-facing startup role.
Added 28 mins ago
U
Directeur principal, Ingénierie logicielle – WFM / Sr Dir. Software Development - WFM
UKG
Montreal, QC
- Full-time
…l’identité et l’accès, les cadres de travail, l’activation de l’intelligence artificielle, les services de plateforme de base, les rapports, les expériences de flux de travail, les…
Added 44 mins ago
TC
Senior Category Management Specialist
TJX Canada – Winners, Marshalls, HomeSense
Mississauga, ON
- $76,620 to $107,268 CAD / year
- Full-time
…and contracting efforts for all non-merchandise areas of the business. In this role, you will play a key part in supplier selection, driving value for the organization while collaborating…
Added 44 mins ago
PC
Forensic & Dispute Services Senior Associate (Bilingual FR/EN)
PwC Canada
Montreal, QC
- Full-time
As a Forensic & Dispute Senior Associate (Bilingual FR/EN), you’ll work as part of a team of problem solvers, helping to solve business issues, deliver high quality client service and…
Added 44 mins ago
Director Technology Transformation Stores
Sobeys Capital Incorporated or a Franchise/Affiliate / ou une franchise/société affiliée
Stellarton, NS · Mississauga, ON
…that is operationally resilient and secure to achieve expected business…
Added 44 mins ago
OH
Regional Financial Director, FP&A
O’Dell HVAC Group
Burlington, ON
- Full-time
…to the SVP, Operations & Performance, you will partner with senior leadership to guide financial planning, forecasting and business performance…
Added 59 mins ago
HN
Market Sales Director
Harvey Nash
Canada
- Full-time
…180° Sales Executives focused on client development and new business generation, alongside 360° Specialist Consultants responsible for both client and candidate…
Added 59 mins ago
SU
Corporate Security Officer (CSO) , Canada
Saab UK
Ottawa, ON
- Full-time
…the President of Saab Canada Inc., you will work closely with business leaders in Canada and Sweden to ensure security considerations are integrated into Saab’s strategic planning, growth…
Added 59 mins ago
BT
Senior Director, Technical Development Lead, Device
BlueRock Therapeutics
Toronto, ON
- Full-time
…regulatory‑compliant, and aligned with patient, clinician, and business…
Added 1 hour ago
WC
Senior Manager, Data Analytics
Walmart Canada
Mississauga, ON
- Full-time
The Senior Manager, Data Analytics & AI Transformation is responsible for leading the development, maintenance and continuous improvement of data, analytics and AI-enabled tools that…
Added 1 hour ago
WC
Senior Manager, Merchandising Planning
Walmart Canada
Mississauga, ON
- Full-time
As a key strategic and financial partner to Merchandising, the Senior Manager provides insights and recommendations to inform assortment, pricing, promotional, inventory and go-to-market…
Added 1 hour ago
PC
Forensic and Dispute Services Senior Manager (Bilingual FR/EN)
PwC Canada
Montreal, QC
- Full-time
As a Forensic and Dispute Services Senior Manager (Bilingual FR/EN), you’ll work as part of a team of problem solvers, helping to solve business issues, deliver high quality client service…
Added 1 hour ago
OP
Senior Analyst, Lease Accounting
Oxford Properties Group
Toronto, ON
- Full-time
We are a leading global real estate investor, developer and manager. We combine our capital with our capabilities to create real estate that strengthens economies and communities. By…
Added 1 hour ago
PC
Forensic and Dispute Services Senior Manager (Bilingual FR/EN)
PwC Canada
Quebec, QC
- Full-time
As a Forensic and Dispute Services Senior Manager (Bilingual FR/EN), you’ll work as part of a team of problem solvers, helping to solve business issues, deliver high quality client service…
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
OG
Vice President of Operations / Chief Operating Officer - Canada, GreyOwl
Onni Group of Companies
Vancouver, BC
- Full-time
The successful candidate will bring a combination of operational leadership, business acumen, technology orientation and execution discipline. They will be equally comfortable developing…
Added 1 hour ago
M365 Architect
EY
Toronto, ON
Excellent collaboration and presentation skills, and the confidence to challenge senior colleagues and stakeholders from a diverse range of backgrounds
Added 1 hour ago
ML
Project Controls Manager
Maple Leaf Foods Inc.
Mississauga, ON
- $96,000 to $141,000 CAD / year
- Full-time
We’re a global food company with approximately 10,000 team members. We operate sites in 20+ locations across Canada. We also have locations in the U.S. and Mexico and do business in Asia.
Added 1 hour ago
RB
Senior Director, Data Architecture & Engineering
Royal Bank of Canada
Toronto, ON
- Full-time
The Senior Director, Data Architecture simplifies and unifies RBC's data architecture across the full lifecycle: manufacturing, distribution, discovery, consumption and governance. They own…
Added 1 hour ago
IW
Senior Manager, Solution Architect 1
IG Wealth Management
ON · Ontario, Canada
- Full-time
Founded in 1926, IG Wealth Management is a key part of IGM's business model, providing comprehensive wealth management services to Canadian financial advisors and their clients.
Added 1 hour ago
B
Property Manager
BGIS
MB · Manitoba, Canada
- Full-time
Meet with property management team, tenants, vendors, contractors & senior management as needed to review & provide support to resolve operational challenges & implement new initiatives
Added 1 hour ago
IW
Senior Compliance Specialist, Compliance
IG Wealth Management
Quebec, QC
- Full-time
We are currently looking for a Bilingual Senior Compliance Specialist to join our Compliance team. The mandate of the Compliance Department is to ensure compliance with relevant regulatory…

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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