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Jobs - Join our Team


Associate Director -  Product Engineering

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Position Overview: 
 

The Associate Director, Product Engineering is responsible for planning and managing the design, development, and manufacturing of Morphocell Technologies’ devices and combination products. This role may involve hands-on technical contributions, leadership of direct reports or cross-functional project teams, and project management throughout the product development lifecycle. The Associate Director also provides engineering support for existing products.

This position offers a unique opportunity to contribute to cutting-edge cell therapies in a collaborative and innovative environment. The role is on-site and requires relocation to the Greater Montreal Area.

 

Key Responsibilities: 

 

  • Manage product development of novel combination products and their related delivery systems and packaging. Oversee or lead key development activities such as defining voice-of-customer, proof-of-concept, verification/validation testing and tech transfer through to successful product launch. Support our Discovery, Preclinical, and Process teams as needed.

  • Guide device and combination product encapsulation process development to identify end-to-end solutions. Identify scaling/ optimization opportunities, establish user requirements and implement solutions to address technical challenges in the manufacturing process to support short- and long-term manufacturing needs.

  • Technically lead specific research efforts in support of organizations technology pipeline and/or innovation within current product portfolio. Maintain strong and consistent knowledgebase on industry landscape and pre-clinical/clinical research.

  • Ensure compliance with Morphocell Technologies Quality Management System by managing and implementing the design control process for new or existing medical devices and combination products, including requirements definition, design planning, verification and validation activities, FMEA development, etc.

  • Provide on-site mentorship and leadership to the Product Engineering team to accomplish all team goals and objectives. Develop team by assigning goals and projects that challenge and advance technical and leadership abilities of members. Foster environment of accountability and effective communication. Provide one-on-one mentorship to team members.

  • Provide collaborative combination product and device manufacturing support through ongoing sustaining engineering efforts. Lead equipment troubleshooting and root cause analysis efforts on pilot manufacturing lines in timely fashion with solution-focused mindset.

  • Guide the conceptualization of new methodologies, materials, equipment, processes or products related to the company’s proprietary medical device, cell, and combination product technologies. Work with legal and engineering teams to generate and protect new intellectual property as appropriate.

  • Author, amend, and review SOP’s, verification studies, batch records, raw material specifications, drawings and other documentation as required for device, cell or combination product.

  • Generate and present scientific data, including scientific papers and research reports.
     

Educational Background:

 

B.S., M.S., or PhD in biomedical, chemical engineering, or related engineering field is required. Minimum of seven years of work experience in medical device development.

An equivalent combination of education and experience sufficient to successfully perform the job duties as listed above is acceptable.

 

Experience / Knowledge / Abilities:

  • Experience managing the development and manufacturing of medical devices and/or combination products.

  • Proven leadership of R&D engineering teams in collaborative, fast-paced environments.

  • Hands-on experience developing and implementing medical device design controls, preferably for implantable devices.

  • Strong foundation in cell biology, physiology, and aseptic techniques.

  • Demonstrated experience with FDA Quality System Regulations (QSR) and ISO 13485 standards.

  • Experience authoring and executing equipment validations (IQ/OQ/PQ), as well as verification and validation testing for medical devices.

  • Strong verbal and written communication skills, with the ability to effectively communicate across technical and non-technical audiences, including cross-functional teams and external stakeholders.

  • Demonstrated attention to detail and sound judgment, with the ability to independently review data, procedures, protocols, and reports, and make informed decisions with minimal supervision.

  • Proven ability to organize and prioritize team activities to meet critical project milestones.

  • Experience working in office and laboratory environments in compliance with standard safety practices, with potential exposure to biological and chemical hazards.

  • Physical ability to perform job duties in office and laboratory settings, including use of standard office equipment, lifting up to 20 pounds, and maintaining focus despite interruptions.

  • Availability to work occasional weekends, as required.


Why Morphocell:

  • Join a dynamic team of professionals committed to pushing the boundaries of cell therapy.

  • Contribute to groundbreaking advancements in the field of biotechnology.

  • Opportunity for personal and professional growth in a fast-paced and collaborative environment.

  • Competitive compensation package and benefits.
     

If you are a highly motivated professional with expertise in cell therapy preclinical development and have a passion for driving innovation, we invite you to apply and be part of our mission to revolutionize patient care through cutting-edge therapies.  Please submit your resume and cover letter to: career@morphocell.com
Please note that only selected candidates will be contacted for an interview.

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