We are seeking a talented Senior Product Engineer with extensive electrical engineering experience in the medical device industry to join our team. As a key member of our engineering department, you will play a critical role in the development, maintenance, and enhancement of our cutting-edge medical devices.

Key Responsibilities: 

• Work closely with an interdisciplinary team in the design, development, and implementation of new medical devices from concept to commercialization.
• Utilize your expertise in electrical engineering to ensure the successful integration of various components in medical device systems.
• Manage and maintain Device History File (DHF) and Device Master Record (DMR) in compliance with regulatory requirements.
• Plan, create and execute design verification and validation test protocols in adherence to quality standards and regulatory guidelines.
• Collaborate with contract manufacturers to optimize manufacturing processes and ensure product quality and scalability.
• Drive continuous improvement initiatives to enhance product performance, reliability, and cost-effectiveness.
• Investigate product failures, non-conformances, and complaints, as needed.

Qualifications: 

• Bachelor’s degree in electrical, systems engineering or equivalent engineering discipline; advanced degree preferred.
• Minimum of 10 years of experience in the medical device or a regulated industry, with a proven track record of successful product electrical engineering.
• Proficiency in managing DHF, DMR, and other regulatory documentation in compliance with FDA and ISO standards preferred.
• Strong knowledge of engineering principles and practices, including design controls, risk management, and verification/validation processes preferred.
• Experience working with contract manufacturers and outsourcing partners to bring products to market.
• Excellent communication, leadership, and problem-solving skills.
• CAD experience with Solidworks is a plus.
• Project Management certification (e.g., PMP) is a plus.

Workplace type: In office

Job location: Toronto, Ontario, Canada 

Job type: Full-time

To apply, please submit your resume to careers@spinafx.com

The Director of Clinical Affairs and Operations will be responsible for the implementation and administration of all clinical activities related to domestic and/or international clinical studies to assure conformance to regulatory and company objectives. This includes coordination and execution of all operational aspects of clinical studies. They will also be responsible for preclinical studies in support of clinical goals. 

Responsibilities: 

• Develop preclinical and clinical study objectives, strategy, scope and schedule to meet company objectives. 
• Research and develop appropriate study materials, including protocols, consent materials and case report forms, to support both preclinical and clinical investigations. 
• Conduct all preclinical and clinical studies according to: 
  • The protocol and associated materials 
  • The local regulatory body  
  • The local regulations 
  • The competent authority 
  • The governing laws and guidelines 
  • Perform/oversee study site qualification/initiation and monitoring activities. 
• Train clinical sites to study protocol, complete case report forms and Adverse Event (AE) reports and maintain good clinical practices. 
• Oversee management of study data, including accuracy of data collection, CRF audit with source documents and queries, data entry, and analyses. 
• Assist investigators in generating written reports of clinical results for regulatory agencies or scientific meetings.  
• Disseminate clinical results to others in the company. 
• Participate in design reviews of new products. 
• Develop study budgets (staff and study related), including assisting with study compensation and reimbursement payments. 
• Negotiate clinical trial agreements, clinical service agreements and agreements for preclinical study activities. 
• Manage domestic and international clinical personnel. 
• Obtain clinical feedback from external expert consultants to support new clinical product development. 
• Develop standard operating procedures for Clinical Affairs. 
• Procure clinical supplies. 
• Report to CEO, COO and CMO on the clinical progress of the company. 
• Comply with ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. 
• Comply with ISO 13485, EU Medical Device Regulations, FDA 21 CFR, Part 820, Quality System Regulation, and MDSAP concerning Quality Management System for medical devices. 
• Mentor/supervise domestic and international clinical personnel to ensure compliance with regulations and company objectives and support advancement.  
• Coordinate and nurture working relationships with external expert consultants to obtain clinical feedback and expert medical opinions for clinical applications. 

Qualifications:  

• BS minimum or an MS in a scientific discipline, such as medical/scientific field, biological science, RN or similar, or equivalent experience.  
• 10+ years of clinical research experience and management in a Class II or III medical device setting. Sound knowledge of good clinical practice (GCP) with good written and verbal communication skills. Familiarity working in a hospital environment and collaborating with physicians/nurses in a clinical environment. Experience working with the FDA through the entire IDE process.  

Skills:  

• Strong knowledge of good clinical practice (GCP) and regulatory compliance guidelines. 
• Proficient in running multi-site clinical studies (domestic and international) and clinical research design.  
• Ability to grasp technical issues and concepts as well as strong organizational skills.  
• Proficient with computer skills. 

Workplace type: Remote/Hybrid. The work environment may be in the office or off site where clinical studies are conducted. Work will involve domestic and international travel up to 40%. 

Job location: Toronto, Ontario, Canada  

Job type: Full-time 

To apply, please submit your resume to careers@spinafx.com

The Product Development Engineer will report to the CIO. They will be responsible for product development using design controls and project management. The Product Development Engineer will oversee and manage supplier and contract manufacturer activities.  

Responsibilities:  

• Develop medical device for market release. 
• Investigate and evaluate existing technology. 

• Design and implement new methodologies, materials, machines, processes, or products to bring concepts to market, including essential product and process documentation. 
• Source and identify suppliers and components for incorporation into devices. 
• Conduct feasibility studies of the design to determine ability to function as intended. 
• Maintain detailed documentation throughout all phases of research and development. 
• Work with mechanical designers to create new designs with proper documentation. 

• Provide technical support to production/contract manufacturing partners, including inspection activities, as needed. 
• Generate product or process qualification protocols and test reports for product design verification and validation testing and conduct product or process qualification testing. 
• Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. 
• Investigate product failures, non-conformances, and complaints, as needed.  
• Perform purchasing activities, as needed.  

• Comply with ISO 13485, EU Medical Device Regulations, FDA 21 CFR, Part 820, Quality System Regulation, and MDSAP concerning Quality Management System for medical devices. 

Qualifications:  

• Minimum bachelor’s degree in mechanical or biomedical engineering. 
• Minimum 5 years in medical device product design and development.  

Skills:  

• Familiarity with ISO 13485, MDR, and FDA Quality System Regulation.  
• Demonstrated ability to bring a product from concept to market and to interact with client companies professionally.  
• Proficiency in Solid Works and 3D CAD.  
• Understanding and experience with fluid path, software development, optical, and high voltage electrical design.  
• Knowledge of probability, statistics, and basic physiology along with knowledge in one or more technical areas, such as thermodynamics.  

• Project management, leadership, communication and presentation skills are a plus. 

Workplace type: Remote/Hybrid 

Job location: Toronto, Ontario, Canada  

Job type: Full-time 

To apply, please submit your resume to careers@spinafx.com