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Added 11 mins ago
ST
Value Optimization Engineer
SEGULA Technologies
Windsor, ON
- Contract
You will collaborate with Engineering, Purchasing, Manufacturing, Quality, Finance, CAE, and suppliers to develop solutions that improve vehicle value while maintaining performance, safety,…
Added 11 mins ago
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Senior Contracts Administrator
Brunel
SK · Saskatchewan, Canada
- Contract
Support the development and negotiation of commercial solutions to contractual issues.
Added 11 mins ago
KS
Rebar Sales
Kit Steel Inc.
Welland, ON
- Full-time
…construction projects, providing reliable and customized reinforcement solutions. Kit Steel Inc. has contributed to notable projects such as the Canada Summer Games multi-sport facility at…
Added 11 mins ago
SH
Sunglass Hut Market Manager Prairies North
Sunglass Hut
Fredericton, NB
- Full-time
A world leader in the specialty sunglass retail business with over 3,000 stores worldwide, we believe in the freedom of self-expression, inclusivity and authenticity, which is why we bring…
Added 11 mins ago
AC
Reward and Equity - Manager
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Calgary, AB
- Full-time
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Added 11 mins ago
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Client Solutions Lead
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Montreal, QC
- Full-time
…transformation and achieve extraordinary results. As a Fortune 500 Solutions Integrator with deep expertise in cloud, data, AI, cybersecurity, and intelligent edge, we guide organisations…
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Conseiller(ère) principal(e) à la transformation
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- Full-time
Anticiper, évaluer et atténuer les risques, enjeux, dépendances et contraintes, puis développer et mettre en œuvre des solutions adaptées.
Added 11 mins ago
Human Resource Manager
Enzo
Caledon, ON · Toronto, ON
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Added 25 mins ago
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Corporate Finance Senior Associate (Bilingual FR/EN)
PwC Canada
QC · Clarke City, QC
- Full-time
A career within Deals Corporate Finance services will provide you the opportunity to deliver innovative deal solutions to our clients, providing advice and support, from initiation through…
Added 25 mins ago
CC
Bilingual Technical Pre-Sales Consultant-Hybrid
Canon Canada
Quebec, QC
- $71,300 to $82,000 CAD / year
- Full-time
…Canon’s hardware and software portfolio with complex customer business requirements. The role centers on conducting deep-dive discovery and needs analysis to engineer scalable, high-impact…
Added 25 mins ago
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TV and Digital Sales Representative – Business Development (French Services) (Telework/Hybrid)
Radio-Canada
Montreal, QC
- Part-time
Reporting to Montreal Sales leadership, you will play a key strategic role focused on active business development and acquisition of untapped markets. As a true prospecting strategist, your…
Added 25 mins ago
BG
Assistant General Manager - Civil Designs
Bondada Group
Burlington, ON
- Full-time
The role will be responsible for developing technically robust, cost-effective and constructible civil and structural solutions for large-scale solar & BESS projects, while ensuring…
Added 25 mins ago
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Intern - Product Management, Winter 2027
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- Volunteer
…services from banking and lending, to trust and credit union…
Added 25 mins ago
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Business Development Manager
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- Full-time
You will develop your market, create and build a self-generated pipeline, establish credibility with business owners and decision-makers, uncover business needs and develop relevant digital…
Added 25 mins ago
HS
CA Payroll Coordinator
Henry Schein Canada
Niagara-on-the-Lake, ON
- Full-time
…Service, And Digital Technology Driven Through An All-encompassing Business Solutions Approach Which Brings Our Corporate Mission To…
Added 25 mins ago
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Specialist Product Management-CA
CN
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- Full-time
Translate business and operational needs into concrete technical solutions through a formal product roadmap
Added 25 mins ago
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Account Executive, Commercial Interiors
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Vancouver, BC · Greater Vancouver, BC
- Full-time
…can leverage those relationships to identify and develop new business…
Added 25 mins ago
IG
D365 F&O Developer
Insight Global
Canada
- $87 to $100 CAD / hour
- Contract
…and web-service integrations using REST, SOAP, and OData. The developer will partner closely with functional analysts, technical leads, and business stakeholders to translate requirements…
Added 25 mins ago
DI
Senior iOS Developer
Dawn InfoTek
Toronto, ON
- Contract
…organizations. We are committed to delivering innovative technology solutions and connecting top-tier IT talent with leading…
Added 25 mins ago
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Senior Manager, Data Governance (36122)
Myticas Consulting
Toronto, ON
- Full-time
…and services, including lending, money transfers, and payment solutions. With a strong national presence, the organization is committed to delivering accessible financial solutions through…
Added 25 mins ago
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Technical Consultant III (35732)
Myticas Consulting
Toronto, ON
- Full-time
…implementation areas, or engineering squads. You will translate complex business and banking requirements into scalable technical solutions, guide junior and intermediate engineers and…
Added 25 mins ago
SI
Software Developer
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Design, develop, and maintain software applications based on business requirements.
Added 25 mins ago
IG
Sr. Product Owner
Insight Global
Toronto, ON
- $70 to $75 CAD / hour
- Full-time
Connecting solutions to business value and communicating impacts of delivered work
Added 26 mins ago
RF Developer
Sonova AG
Kitchener, ON
As an RF Developer, you will play a key role in developing the next generation of wireless technologies that power our innovative hearing solutions.
Added 26 mins ago
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VRF & Ductless Technical Support Representative
Refrigerative Supply Limited
Abbotsford, BC · Burnaby, BC · Coquitlam, BC · Langley (District), BC · Vancouver, BC · Langley, BC
- Full-time
Refrigerative Supply Limited is a family business owned by Alison Hamilton and Linda Gibbs. The business was founded by Peter Gibbs' and Alison Hamilton's parents, Jack and Elizabeth Gibbs.…

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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