• Build and foster meaningful, trust-based relationships with new clients providing them with exceptional communication and support at every step of the way• Spearhead the planning and execution of projects to integrate with the overall development plan• Lead teams developing new products and novel technologies from initial concept through detailed design• Work closely with clients, team members, and vendors to ensure that schedules are met, and budgets are controlled.• Develop strategic program plans, risk management plans, program charters and product roadmaps• Partner with clients to identify product requirements and needs for new projects • Strategically manage expectations with clients, including exploration of “need” vs “want” and presenting trade-off evaluations to support decision-making and priorities.• Oversee the work of team members to ensure compliance with regulatory standards, company procedures, product requirements, and specifications.• Coach and mentor others in all aspects of Strategic Project Management and Product Development• Prepare proposals, budgets, and timelines for highly complex multi-year medical device development programs.

• Accountable for the successful execution of all assigned projects, where success includes on-time, on-budget, high quality/compliant project results• Create and execute comprehensive project development plans (PDP) • Develop and adhere to project budgets in excess of $1M• Manage the progress of milestones and device development• Work closely with QA to develop testing, verification, and validation processes• Work with regulatory bodies (FDA, CE, Health Canada) to ensure the proper release of a medical device• Lead risk management and product development in accordance with ISO 13485, MDSAP & MDD• Review and redline documentation for regulatory submissions including FDA 510(k), CE technical file, and Health Canada MDL • Identify and resolve risks and issues to meet project deadlines and budgets• Keep logs for Risks, Issues, Actions, and Decisions (RAID Logs) • Create and maintain a list of “Lessons Learned”, which are reviewed at each phase of the project • Lead a team of internal and outsourced developers, engineers, and vendors (software, hardware, mechanical, and electronics)• Work in an Agile environment to manage projects using software such as MS Project, JIRA, Confluence, etc.• Manage the product release, including scale-up and transfer to manufacturing.• Write, review and approve SOPs• Provide technical support to other departments• Review and update documentation, such as Requirements, Design Descriptions, Architectures etc.• Assist in verification and validation activities (V&V)

• Lead the development and successful roll out of products and services to support implementation of the company’s business plan.• Identify and develop vendor relationships for purchase of raw material, finished goods, equipment and machinery in Canada, US, and offshore (China and Taiwan).• Ensure smooth transition of new products to manufacturing including procurement of required machinery and tools.• Identify opportunities and demand (market) for new and innovative products and services for development.• Propose innovations and improvements.• Identify funding and resource requirements for the development of new products and services.• Create and control a yearly departmental budget.• Manage development projects ensuring scope, schedules, and budgets, are met.• Oversee the monitoring and evaluation of product/service implementation and set up a performance reporting system to be able to provide regular progress reports to the president and senior management.• Maintain a permanent benchmarking of products, processes, and performance (market and industry).• Assist the Director of Sales and Marketing with input into the three-year business plan and sales forecast.• Contribute to production, forecasting, and marketing meetings.• Maintain records and databases of all aspects of the department (i.e. quotes. Schedules, proposals, meeting minutes, white papers, legal papers, etc.).

• Led the entire process of New Product Planning, New Product Introduction and Life Cycle Management • Acted as the voice of the customer within the organization based on both direct interaction with the customer base and also through customer facing organizations such as Sales, Marketing and Service • Developed specifications for new products that meet the market needs• Conducted ongoing Market research and Competitive assessments• Identified new markets and potential customers for existing and future products• Travelled to and participated in trade shows, conferences and seminars• Led cross functional teams through various phases/stages during product life cycle including: Concept Phase, Product Definition Phase, and Life Cycle Management• Participated in product development meetings and worked with engineering to ensure specifications were met and project was on time• Supported Sales and Marketing with information, sales kits, price lists, training materials, training and demo support etc.• Coordinated the field trials with customers and the sales force • Led development of overall Product Roadmap for the product and product portfolio• Ensured that individual product plans and strategies meet with the overall company goals and strategies• Developed pricing strategies for the product, accessories, consumables and replacement/spare parts• Coordinated, assisted with and wrote Quad Charts, White Papers and Proposals for funding submissions to government agencies, private corporations and internally resulting in funding for projects ranging from $300,000 to over $2 million.• Worked with Marketing Department on product launches, timing and supporting materials

• Coached, guided and mentored a team of customer service and tech support representatives• Worked closely with customers, sales, and management to ensure highest level of service and support is provided at all times• Wrote comprehensive reports regarding product performance and quality as well as customer’s satisfaction, perceptions, issues and concerns. Presented information, data and proposed actions to management • Translated customer feedback into product requirements and specifications and worked closely with vendors to create more desirable packages• Defined resource and skill requirements for proper staffing. Hired and trained staff as required.• Held regular training sessions with sales staff on technical aspects of the products to ensure that customers are correctly informed prior to making their purchase decision. This approach reduced product returns by nearly 50% within three months.

Production Supervisor (1997 – 2000)• Supervised a team of technicians and technologists• Made suggestions to management on improving products and procedures. • Implemented changes as required to maintain superior quality and ability to uphold the lifetime warranty offered on all products• Maintained excellent communication with customers, suppliers and management• Ensured appropriate inventory levels of parts and products are maintained at all times. Created a comprehensive database to facilitate this process.Production/Service Technician (1993 – 1997)• Built broadcast equipment to the highest quality standards.• Repaired products in a timely and efficient manner• Provided over-the-phone service and troubleshooting