Department:

Sales and Marketing

Reports to:

VP Sales and Marketing

Responsibilities:

The Clinical Applications Specialist owns the clinical adoption of Focal products and ensures that his/her designated customer sites achieve the greatest clinical benefit from these solutions. This responsibility spans pre-sales support, post-sale applications, customer care activities and other sales process activities. This role includes the following primary responsibilities:

• Lead on-site clinical application training to: physicians, nurses, imaging technologists and support staff
• Provide procedure support for clinical cases
• Build relationships with clinical teams at customer sites
• Identify and troubleshoot product issues
• Provide education to the sales and marketing teams to increase their knowledge of our products
• Provide product demonstration support to the sales and marketing teams
• Actively solicit customer feedback and communicate this to product management and regulatory departments
• Write reports, assist with user and technical manuals.
• Any other duties as assigned

Qualifications:

• Excellent ability to teach and coach, a clinical team including: assistants, clinicians, hospital administrators, etc.
• Excellent written and oral communication skills
• Strong trouble- shooting skills
• Computer skills including MS Office, Customer Relationship Management tools
• Open to traveling, up to 80% of the time (Canada and USA)
• Strong organization and ability to multi-task and make independent decisions while working in a fast-paced environment with multiple priorities
• Demonstrated ability to quickly understand and communicate technical concepts to individuals with and without technical backgrounds
• Ability to work well independently as well as within a team
• Aptitude and appetite for learning new technologies
• High level of integrity, confidentiality, and accountability
• High degree of professionalism, courteousness, and friendliness
• Ability to work in a highly regulated environment: learn and adhere to internal policies and procedures, applicable regulations, and quality standards

Education and Experience:

• A college/university degree or equivalent work experience
• A minimum of 12 months experience working as a sonographer on a clinical team
• Experience with product demonstration, installation, training, and/or teaching
• Fluency in English required
• Valid driver’s license is mandatory
• Ability to travel to the United States
• Preferred: experience working with MRI and PACS
• Preferred: experience working in a regulated environment, ideally with medical devices
• Preferred: Fluency in Mandarin

Work Conditions:

• Travel is required.
• Ability to attend and conduct presentations and hands-on product demonstrations.
• Overtime may be required.
• Lifting or moving up to 50lbs may be required.

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Clinical Applications Specialist” in the subject line.

Department:

Reports to:

Responsibilities:

• Participate in overall systems architecture, while coordinating with cross-function teams on trade-offs and constraints
• Design mechanical parts and assemblies for magnetic resonance imaging/ultrasound fusion biopsy products
• Perform tolerance analysi.
• Ensure product features achieve cost, schedule, reliability, and regulatory/safety goals
• Work closely with internal and/or external partners to generate all necessary documentation and test plans to ensure products meet specifications
• Work with a team of engineers that is passionate about creatively solving clinical challenges and impacting the lives of prostate cancer patients
• Contribute in a meaningful way to effectively improve our products

Qualifications:

• Ability to design and implement creative solutions related to prostate cancer detection and care
• Can translate rough ideas into functional products under the guidance of Product Management
• Must be detail-oriented with good organizational skills
• Possess effective communication skills for both oral presentations and written content
• Knowledge of ISO 13485 and FDA documentation requirements is an asset

Education and Experience:

• Proficiency with 3D CAD software for part and assembly design and documentation (SolidWorks preferred)
• Hands-on experience with standard shop tools – e.g. concept mock-ups, prototypes, and fixture development
• Broad understanding of mechanical materials and manufacturing processes
• Minimum bachelor’s degree in mechanical engineering or equivalent

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Posting ID SD-0488” in the subject line.

Department:

Reports to:

Responsibilities:

• Manage a team of Software Developers by determining/assigning development tasks, monitoring progress and providing support where required
• Ensure the quality of software delivered by the development team meets requisite quality and regulatory standards requirements
• Communicate business and development needs to development team and management, respectively
• Lead software design and implementation per product requirements and specifications
• Diagnose and propose/implement solutions to issues identified in Focal Healthcare’s software products
• Provide detailed documentation of software design and implementation

Qualifications:

• 3-5+ years of software development experience in C# Experience with leading a team of software developers
• Familiarity with user interface frameworks (WPF) and design patterns (MVVM)
• Familiarity with visualization software tools such as OpenGL, as well as general graphics and 3D mathematics techniques
• Experience or familiarity with medical device SDLC (ISO 13485, IEC 62304)
• Experience with SCM (Git preferred)
• Experience with DevOps (Jenkins preferred)
• Experience with following and adapting development methodologies (Kanban, SCRUM, etc.)
• IT knowledge is an asset (network infrastructure and diagnosis/debugging)
• Strong written and oral communication skills

Education and Experience:

• Minimum bachelor’s degree in computer science, engineering, or related field
• Minimum 5 years of experience in software design and development in a team environment

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Lead Software Developer” in the subject line.

Department:

Reports to:

Responsibilities:

• Design and implement software related to: image viewing, image analysis and processing, multi-threading architectures, and graphical pipelines
• Work with a team of engineers that is passionate about the optimal user experience
• Contribute in a meaningful way to effectively improve our products

Qualifications:

• Ability to design and implement solutions related to prostate cancer detection and care
• Experience with C# and Windows desktop application development
• Experience with OpenGL
• Knowledge of medical imaging and image analysis is an asset

Education and Experience:

• Minimum 2 years of experience with C# for Windows desktop applications
• University degree in a life science or related field
• Bachelor’s degree in computer science, or related engineering field

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Software Developer” in the subject line.

Department:

Reports to:

Responsibilities:

• Develop and support the implementation of a Quality Management System (QMS) in compliance with ISO 13485 standard, FDA Quality System Regulation (QSR), and regional regulatory requirements
• Control and maintain QMS documentation, author and review SOPs, manage staff training program, and support implementation of company policies and procedures, including corrective and preventative actions (CAPA) and post-market surveillance activities
• Assist with internal and external audits, supporting the company audit program
• Review manufacturing documentation and support investigation of quality related issues
• Support development of Design History Files, ensuring compliance with design control requirements, as assigned
• Support development of global regulatory strategies and submissions, and maintenance of medical device licenses and registrations
• Stay abreast of changing global regulations and standards

Qualifications:

• Excellent technical writing and presentation skills
• Strong knowledge of FDA QSR, ISO 13485, European Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), and Medical Device Single Audit Program (MDSAP)
• Excellent knowledge and experience with Microsoft Office applications
• Organized, detail-oriented, and able to multitask and prioritize responsibilities
• Ability to work under pressure to meet deadlines
• Strong interpersonal and teamwork skills

Education and Experience:

• Experience in Regulatory Affairs or Quality Assurance is highly desired, preferably in the medical device industry
• University degree in a life science or related field
• Basic knowledge in software design is highly desired
• Formal education and training in Quality Assurance/Regulatory Affairs is highly desired

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected]

Department:

Reports to:

Responsibilities:

• Facilitate all aspects of the fund-raising process, including manage and update investor related materials, identify, reach out and pitch to investors
• Identify and manage the application for relevant grants, subsidies and funding programs
• Conduct on-going research and analysis for new markets and new business opportunities
• Manage company project timeline/execution on an ongoing basis
• Create and maintain financial projections
• Assist the preparation of reporting packages and relevant company information for shareholders
• Maybe required to attend industry conferences and events
• Maintain and develop knowledge of products and services, staying current in terms of industry trends and innovations
• Communicate in a timely and effective manner with all key internal and external stakeholders
• Providing advanced administrative support to the corporate team and CEO
• Perform other duties as required

Qualifications:

• Ability to work in a multidisciplinary team independently with minimal supervision and manage deadlines
• Accurate and detail-oriented with a high level of initiative
• Active listening and ability to work as part of a team
• Commitment to high quality work
• Possess the following personal qualities: self-motivated, integrity, creativity, high standards, commitment, ethical values, and achievement oriented
• Excellent organizational, strategic, planning and implementing skills
• High level of critical and logical thinking, analysis, and/or reasoning to identify underlying principles, reasons, or facts
• Ability to follow through and complete overlapping projects
• Able to create realistic schedules and meet deadlines under stress and interruptions
• Understanding of financial reports including budgetary guidelines and project expenditures
• Expert understanding of accounting principles, database and information systems
• Computer literacy, including effective working skills of MS Word, Excel, PowerPoint, Adobe products and e-mail required
• Excellent management writing and verbal communication skills
• Strong presentation, written, and verbal skills
• Fluency in Mandarin is considered an asset

Education and Experience:

• Minimum Bachelor’s degree in business, finance, or related field
• Working experience in the medical device industry preferred
• Working experience in business development and office management preferred

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected]

Department:

Reports to:

Responsibilities:

• Plan and organize production schedules
• Re-negotiate timescales or schedules as necessary
• Research and establish contacts with potential new vendors to develop additional or new sources for raw materials
• Maintain production operations in conformance with ISO 13485 and in compliance with applicable regulations (e.g. FDA QSR)
• Assist Regulatory Affairs and Quality Assurance in generating manufacturing related documentation as per ISO and regulatory requirements
• Assist with production processes and all applicable quality control standards
• Organize repairs, routine maintenance and calibration of production equipment and tools as required
• Liaise with suppliers and internal staff relating to product quality and process improvements
• Update manufacturing related procedures and work instruction as required
• Ensure inventory is properly identified, organized and controlled
• Establish workflow policies to optimize speed and efficiency without compromising product safety or integrity
• Develop Validation Master Plans for manufacturing processes and write and execute validation protocols in accordance with established regulations, policies, and procedures
• Provide technical support for continuous improvement efforts by conducting root cause analysis and then formulating and implementing corrective action proposals
• Perform research on technology, equipment and tooling to improve process quality, yield or cost
• Support process risk assessment activities in order to identify critical process parameters and develop appropriate control plans to mitigate risks

Qualifications:

• Ability to manage multiple tasks for various projects
• Ability to perform in a highly efficient and organized manner
• Strong technical, analytical and problem solving skills
• Ability to communicate clearly, concisely and in a timely manner, both verbally and written
• Experience with process design, medical devices, lean manufacturing techniques and/or ISO quality management systems is preferred
• Knowledge of 3D modeling software, prefereably Solidworks, is an asset
• Demonstrate creativity, enthusiasm and a positive attitude
• Ability to work in cross- functional teams

Education and Experience:

• Bachelor’s degree in a science discipline
• Minimum of 1 year of relevant work experience
• Knowledge of medical device ISO quality system preferred

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected]

Department:

Reports to:

Responsibilities:

• Lead product defect identification, tracking, regression, testing, impact, and workarounds
• Investigate and reproduce software anomalies experienced in the field
• Collaborate with the Testing team on product testing methodologies
• Review and interpret business and functional requirements when creating/defining test plans, test protocols, test scenarios and test cases
• Read and interpret technical specifications
• Investigate and resolve corrective or preventive actions as required
• Support investigation of existing and new product features
• Provide detailed analysis of unexpected anomalies and monitor reproduction as appropriate
• Other duties as required

Qualifications:

• Excellent problem-solving and troubleshooting skills
• Excellent written and verbal communication skills
• Strong understanding of QA methodologies and Testing processes
• Proficiency utilizing Test Case Management systems for both test case writing and execution. Experience with TestRail is an asset
• Proficiency with source control and defect tracking systems. Experience with Jira is an asset
• Knowledge of and experience in Test Automation not required but an asset
• Good understanding of the SDLC and experience working in Agile Development (scrum preferred)
• Programming and software architecture skills not required, but an asset
• Ability to work independently when required
• Excellent organization and time management skills
• Strong interest in the healthcare industry

Education and Experience:

• Minimum of bachelor’s degree in engineering (e.g. computer, electrical, mechanical, mechatronics, biomedical and systems design), in computer science or another relevant field
• At least 1-2 years experience in a software testing role
• Experience in a hardware testing role not required, but an asset
• Experience with FDA/ISO 13485 cleared medical devices is preferred
• Experience with testing .NET desktop applications is preferred

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Software Engineering Test Associate (Development)” in the subject line.

Department:

Reports to:

Responsibilities:

• Represent the company appropriately to potential external stakeholders, including investors and business partners
• Develop a growth strategy focused both on financial gain and client satisfaction
• Facilitate all aspects of the fund-raising process, including manage and update investor related materials, identify, reach out and pitch to investors
• Conduct on-going research to identify new markets and new business opportunities
• Drive sustainable financial growth through boosting sales and forging strong relationships with clients
• Manage company project timeline / execution on an ongoing basis
• Maintain and develop knowledge of products and services, staying current in terms of industry trends and innovations
• Providing advanced support to the corporate team and CEO

Qualifications:

• Strong skills in communication and organization and planning with a demonstrated ability to work independently and exercise sound judgment and problem-solving
• Ability to respond appropriately in pressure situations with a calm and steady demeanor
• Excellent management writing and verbal communication
• Active listening and ability to work as part of a team
• Accurate and detail-oriented with a high level of initiative
• Willing to travel frequently within Asian countries
• Fluency in English
• Fluency in Mandarin is considered an asset

Education and Experience:

• Minimum Bachelor’s Degree in Business, Finance or related field
• Existing relationship within the Chinese healthcare investment community
• Knowledge of medical device industry considered an asset

Work Hours:

• 35 hours a week

Salary:

• $61,250 per annum

Focal Healthcare is committed to accessibility and accommodation for persons with disabilities, and will provide all appropriate accommodation upon request.

Please send resumes to [email protected] and include “Business Development Manager” in the subject line.