npaworldwide

Director New Product Introduction (BB-A9C5B)

Found in: Talent CA

Description:
WHY IS THIS A GREAT OPPORTUNITY? We have recently been retained by the leadership team for a North American Leader in advanced multiplexed testing and automated systems. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality. This Canadian company has joined the global fight against COVID-19 by creating innovative triage diagnostics tests for early identification of patients at risk of severe complications due to COVID-19, as well as a direct-to-consumer (DTC) suite of products that will enable you to order health tests from the comfort of your home or business, delivered directly to your door enabling results in 24-48 hours with 99% accuracy. This in addition to outstanding products in custom diagnostics and next generation instrumentation for the biopharma market, requires a Director, New Product Introduction. The Candidate they seek will bring expert level skills in NPI and working under stage gate design processes (or waterfall or similar philosophy), be able to take product from R&D to manufacturing (Design Transfer) to introduction. This will be someone who has done this in a FDA/Health Canada regulated environment and brings experience with products that may require Engineering, science, and or software technologies in a design control environment, and bring them to successful completion. JOB DESCRIPTION Job Description Role The Director New Product Introduction is responsible for the successful delivery of new product designs and services from research and development to manufacturing, clinical/regulatory and sales/marketing internal stakeholders to achieve company's commercial goals. New products and services are developed under stage-gate design process and supported by best practices in project management. The Director ensures that each project establishes a project plan with clear goals and milestones and with sufficient resources identified. The Director monitors closely the project team’s progress to the goals and milestones in the plan. Plans are set in the context of a regulated environment (FDA, Health Canada, MDSAP, ISO13485) which typically requires design work to follow design control processes. The Director supports the project technical leadership / Subject Matter Experts through goals and milestones and supporting project plans. The Director ensures that requirements of quality management systems are met while pursuing the business objectives, defined with the design recipient stakeholders. The Director is the key point of contact to executive leadership for the new product and services portfolio. Job Requirements Responsibilities: There are three key areas of leadership responsibility: New Product Introduction & Design Transfer • Ensures new designs (products, services) are robustly verified and validated prior to a)transfer of the design to production and b) initiation of clinical studies in support of regulatory filings. Designs include assays, instrumentation (hardware, software). • Leads the identification and fulfillment of quality management documentation requirements • Is the lead voice for R&D to the sales/marketing team in commercial product launch activities • These activities are stages 2-5 in company's Stage Gate process • With the stakeholders, builds and maintains project plans • Responsible leader for New Product Introduction projects • Subject-matter expert knowledge of design control requirements and processes required by the relevant regulatory and quality standards • Develop and help maintain compliant design control processes that are best-in-class and are efficient and effective for the business • Uses mature and effective project management tools to manage projects (schedules, resources, risk register) • Overall leadership of the portfolio of projects; ensuring smooth coordination of projects; managing resource conflicts on the basis of business priorities even under changing conditions and situations Stakeholder Management • Uses exceptional people and communication skills to work with internal stakeholders to define and drive the execution of the New Product Introduction stages of design control. Stakeholders include leadership in: technology; manufacturing/operations; clinical; commercial; quality and regulatory; finance • Is proactive in identifying risks and risk mitigation strategies with stakeholders. • Key point of contact to Executive Management on project portfolio. General Leadership Attributes • Excellent communication skills: verbal, written, listening • Continuous energy and realistic optimism • Breaking down complexity into simple components that are understood and executed • Adaptable to different work situations and multi disciplines • Delivers innovative and practical solutions • Perform other duties as assigned Education, Qualifications, and Requirements: • Minimum B. Eng. or B.Sc. degree, preferably graduate level degree in engineering or science or business • Minimum 8 years of experience in technology/business leadership in healthcare sector, with preference for experience in the Diagnostic or Medical Device industries • Demonstrated communication and leadership (project, people) skills General Responsibilities and Accountabilities: • Work tasks have a high degree of complexity • Percentage of independent work is up to 90% • Financial accountability: establish and meet departmental budgets • Leads and directs external vendor/partner/client relationships • Leads people directly (or indirectly) in a project/team environment • Responsible to establish and deliver key business objectives in department • Leadership shapes department culture QUALIFICATIONS Education, Qualifications, and Requirements: • Minimum B. Eng. or B.Sc. degree, preferably graduate level degree in engineering or science or business • Minimum 8 years of experience in technology/business leadership in healthcare sector, with preference for experience in the Diagnostic or Medical Device industries • Demonstrated communication and leadership (project, people) skills General Responsibilities and Accountabilities: • Work tasks have a high degree of complexity • Percentage of independent work is up to 90% • Financial accountability: establish and meet departmental budgets • Leads and directs external vendor/partner/client relationships • Leads people directly (or indirectly) in a project/team environment • Responsible to establish and deliver key business objectives in department • Leadership shapes department culture Education: University - Bachelor's Degree/3-4 Year Degree

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