Senior Manager – Program Management

Senior Manager – Program Management

Requirements

• Minimum of 8 years’ experience in vitro diagnostics (preferred), medical devices industry.
• Demonstrable track record in product development with increasing responsibility leading to management of complex projects and launching new capabilities to market.
• Experience with regulatory submissions (e.g., 510(k), PMA).
• A completed 3 or 4 year college diploma or university degree in one of the following areas: Quality, Science (chemistry, biology, or medical technology), or Engineering.
• Experience with design control processes for medical devices and related processes.
• Deep understanding of project management methodologies and techniques with practical experience using project management tools (i.e., Microsoft Project).
• Strong analytical and problem-solving skills with the capability to simplify complex issues and mitigate accordingly.
• Competency with internal and external audit processes.
• Proficient use of basic computer software (Microsoft Office preferred).
• Excellent verbal and written communication skills with presentation capabilities.

Responsibilities

• Oversee multiple project teams, ensuring program goals are reached.
• Strategize, implement, and maintain program initiatives that adhere to organizational objectives.
• Develop program assessment protocols for evaluation and improvement.
• Maintain organizational standards of satisfaction, quality, and performance.
• Manage budget and funding channels for maximum productivity.
• Work closely with project sponsors, cross-functional teams, to develop the scope, deliverables, required resources, work plan, budget, and timing for new initiatives.
• Identify key requirements for cross-functional teams and external vendors.
• Develop and manage budget for projects and be accountable for delivering against established business goals/objectives.
• Analyze, evaluate, and overcome program risks, and produce program reports for managers and stakeholders.
• Apply product life cycle methodology to the New Product Introduction (NPI) process in collaboration with the project team.
• Plan and define project scope, including establishing objectives, deliverables, and timelines.
• Coordinate with Product Managers and lead cross-functional teams in planning, execution, and communication of key project deliverables.
• Manage project resources, including allocation and management of team members, budget, and equipment.
• Identify potential project risks and develop strategies to mitigate them.
• Keep stakeholders informed and engaged throughout the project.
• Lead and motivate the project team to achieve project goals.
• Ensure that project deliverables meet the required regulations, standards, and specifications.
• Monitor project progress as well as maintain clear and regular communication with cross-functional groups and stakeholders.
• Provide updates to supervisors regarding project status and design control requirements.
• Present program status to senior management for review and approval.
• Facilitate problem-solving and decision-making processes while addressing and resolving project-related issues in a timely and efficient manner.
• Track and control project expenses to stay within budget.
• Maintain comprehensive project documentation for future reference and audits.
• Generate and maintain project management and design control documents, including plans, design control/product realization deliverables tracking, schedules, resourcing, timelines, and budgets.
• Ensure product development timeline and deliverables meet commercial needs for market launch, including product claims, market research, and KOL studies/communication.
• Ensure compliance with relevant regulations and quality standards, including but not limited to U.S. Code of Federal Regulations for Medical Devices, European In Vitro Diagnostic Directives/Regulation, EN/ISO 13485, IEC 62304, and IEC 62366.
• Manage and track product changes.
• Ensure core team personnel understand and comply with the requirements of New Product Development, Design Control, and changes to existing products as applied to the Company’s products.
• Support compilation of design history files and contents for technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to meet Company products and regulatory requirements, and compliance with all approved licenses.
• Participate in the investigation of failures and execution of continuous improvement initiatives.
• Write and maintain procedures relating to product development, the preparation and presentation of reports, data, and Key Performance Indicators for management reviews.
• Maintain current knowledge of related industry trends and regulations as well as integrate lessons learned.
• Comply with the Company’s Quality Systems along with other obligations deemed appropriate for a Project Manager.

Preferred Qualifications

• Project Management Professional (PMP) certification considered an asset.
• Desired experience in product development, for example as a contributing engineer or scientist.