Director, Product Development and Innovation

As a member of the senior leadership team at TMI, this role plays an integral part of driving the acceleration, ideation, design, development, and launch of all new products at TMI, which solve real problems for our patients and customers. In addition to new product pipeline, this role will also manage the maintenance and continuous improvement of product designs for marketed products.

Responsibilities Include:

STRATEGIC DIRECTION

• Lead the innovation and development process for current and next generation products that complement and align with TMI’s strategic goals and initiatives
• Advance TMI’s product design and development activities by promoting innovative methods
• Ensure the success of the overall organization by engaging as an active member of senior management
• Ensure that business objectives are set for Product Ideation, Design and Development as well as Technology Roadmap and cascaded to individual staff members; establish business plans that align with objectives
• Ensure budgets, financial, and management reports are accurate, informative, timely and complete
• Collaborate with Sales & Marketing and other cross-functional teams to deliver a research and development roadmap for next generation products

TECHNICAL SUPPORT

• Participate in technology assessments and due diligence for business development opportunities, drive partnerships and collaboration to create new capabilities across the organization
• Proactively identify and mitigate issues and challenges, optimize key processes, development tools, techniques and capabilities.
• Provide support for currently manufactured products to deliver on business revenue and growth objectives, including product enhancements, material substitutions and sourcing
• Ensure accuracy and completeness of SOP documentation preparation
• Collaborate with and ensure cooperation with Regulatory Affairs staff to provide accurate and complete submissions to national and international regulatory bodies
• Ensure provision of technical assistance internally and externally
• Ensure, or provide directly, external customer service support, e.g., written technical briefs, presentations to customers, creation of customer documentation for new products, etc.
• Ensure provision of support to vendors, i.e., during component selection and approval process during product development

PEOPLE MANAGEMENT

• Cultivate an innovative work environment that sets and maintains an urgent pace for design and development activities, e.g. ensure clarity of expectations, empower people to drive their own projects and initiatives, remove barriers, promote ongoing awareness and scanning of external environments (customers, industry, competitors, regulators, etc.), etc.
• Establish performance metrics and drive accountability to deliver on established time standards and project milestones, balancing the pursuit of the best possible product and time to market considerations
• Ensure employees are treated fairly and equitably, have a sense of self-esteem and are encouraged to develop to their full potential, i.e., by administering workplace policies and programs
• Ensure employees can focus on their jobs, i.e., by resolving employee relations issues, performance problems, and disciplinary issues
• Collaborate with Human Resources to implement training programs that promote rapid development and effective project management

PRODUCT DESIGN AND DEVELOPMENT

• Establish a continuous improvement mindset within the Department, to deliver innovative, quality, next generation products, and value-add enhancements to the existing product portfolio
• Ensure that the Department is positioned to continually learn about or create its own product or process innovations that will lead to commercial success
• Right-size all design and development processes to maximize efficiency

CONTINUOUS IMPROVEMENT AND KNOWLEDGE MANAGEMENT

• Ensure awareness and application of state of the art technologies
• Ensure the team strives for ways to improve (functionality and cost) of existing products
• Ensure application of best practices in process development and laboratory management
• Ensure the creation and development of custom test apparatus for the evaluation of TMI and competitive products
• Ensure awareness and exploitation of intellectual property (IP) requirements and competitor IP details

POLICY AND REGULATORY COMPLIANCE

• Comply with and enforce product development procedures
• Ensure documentation of new ideas in TMI engineering logbook and maintenance of logbook in accordance with TMI’s Inventions Policy and Procedures
• Ensure design development activities are carried out in full accordance with TMI’s Quality Policy and Procedures, including relevant SOPs
• Ensure the creation of complete specifications, including product design and component, assembly, and detail drawings, DFMEA, Moldflow analysis and bills of material
• Ensure the products are developed to meet all regulatory requirements including design controls
• Ensure the preparation of patent invention disclosures and provide technical assistance during patent application process and patent analysis
• Ensure complete and accurate reporting to maximize SR&ED tax credits

HEALTH AND SAFETY

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
• Ensure establishment, maintenance, and adherence to Good Laboratory Practices (GLPs)

QUALIFICATIONS

• Degree in Science, Engineering, Life Sciences or a related field of study
• 15 years of global experience in medical device or related industry, ideally with some
• experience in either respiratory or drug delivery
• Experience in creating innovative strategies and project execution for meaningful
• rapid portfolio growth
• Proven experience in delivering global product launches for multiple devices
• Demonstrated innovation skills with developing a culture of creativity with a focus on
• understanding needs of the end-user
• Demonstrated passion for hands-on leadership
• Ability to cultivate a collaborative, innovative and cohesive work environment
• Knowledge in applicable disciplines, e.g. mechanical engineering, etc.
• Ability to develop and maintain strategic and effective working relationships
• Ability to translate strategic direction into work plans and projects – excellent project
• management skills
• Ability to make complex decisions and communicate with both technical and nontechnical cross-functional teams
• Excellent written and oral communication skills
• Excellent leadership and motivational skills
• Knowledge of regulatory requirements applicable to new product development, e.g.
• ISO Design Controls, FDA, GMP, and HPB
• Advanced experience in database packages
• Advanced experience in internet information acquisition
• Advanced experience in graphical presentation packages
• Advanced experience in mathematical statistics software, e.g. SigmaStat
• Commitment to highest standards
• Commitment to continuous improvement

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.


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