KNG Technical Inc.
Sr. Program Manager
KNG Technical Inc., Los Angeles, California, United States,
Job Title: Sr Program Manager - Remote an OptionRemote in CA for qualified candidate • Clinical DiagnosticsThe Diagnostics Program Management Office (PMO) is seeking a Senior Program/Project Manager who will manage complex New Product Development projects to successful and timely commercial launch. This role will lead cross-functional new product development teams for In Vitro Diagnostics (IVD) devices in accordance with FDA, ISO 13485, and international regulations, as well as company Design Control procedures and phase gate approval processes.The role will also support RUO products, sustaining projects, and PMO departmental initiatives.Responsibilities:
Create and maintain project timelines ensuring project tasks, dependencies, and responsibilities are well defined. Utilize critical path techniques in schedule development and project monitoring.Establish and manage project budgets in collaboration with Finance and cross-functional departments. Ensure contractual obligations and financial milestones are met.Estimate resource requirements over the course of the project and work with management to address resource constraint issues.Facilitate the completion of various design control documents (project plans, design inputs, design outputs, risk, etc.) and maintain design history files to ensure adherence to quality procedures.Identify, document, and mitigate project risks and contingency plans.Collaborate with OEM partners to ensure coordination of timelines, identify critical milestones, risk mitigation, and communication of progress.Lead project team meetings, drive team decisions, and ensure alignment with internal and external partners.Manage scope creep and ensure customer, team, and company needs are met.Promote a proactive, positive, and professional culture within the Program Management Office. Mentor and coach junior Project Managers.Contribute to continuous improvement of PMO processes, related SOPs, and supporting tools.Education/Experience:
Bachelor’s degree in life sciences, engineering, or equivalent. PMP (Project Management Professional) certification strongly recommended.10 years industry experience; 5+ years in Project Management roles with increasing responsibilities.Experience working in an FDA regulated environment is required.Advanced understanding of design control quality standards and regulatory compliance requirements for medical device or diagnostics (ex. 510K submissions). Experience in developing Therapeutic Drug Monitoring (TDMs) Tests, Infectious Disease Tests, Toxicology Tests, QC Controls, or Companion Diagnostic test is preferred.Strong understanding of product development challenges and methods for resolution. High-level business acumen with experience using financial tools.Demonstrated skills using MS Project or related software for Project Management. Solid skills using MS Office, Outlook, Smartsheets, PPM Pro or other project management software.Non-Negotiable Hiring Criteria:
Solid ability to lead complex and virtual cross-functional project teams from feasibility to launch.Outstanding organizational skills with ability to multi-task and balance sophisticated and routine work activities.Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. Strong conflict resolution skills.Excellent written and verbal communication skills with the ability to effectively communicate with team members, functional management, and senior leadership.
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Create and maintain project timelines ensuring project tasks, dependencies, and responsibilities are well defined. Utilize critical path techniques in schedule development and project monitoring.Establish and manage project budgets in collaboration with Finance and cross-functional departments. Ensure contractual obligations and financial milestones are met.Estimate resource requirements over the course of the project and work with management to address resource constraint issues.Facilitate the completion of various design control documents (project plans, design inputs, design outputs, risk, etc.) and maintain design history files to ensure adherence to quality procedures.Identify, document, and mitigate project risks and contingency plans.Collaborate with OEM partners to ensure coordination of timelines, identify critical milestones, risk mitigation, and communication of progress.Lead project team meetings, drive team decisions, and ensure alignment with internal and external partners.Manage scope creep and ensure customer, team, and company needs are met.Promote a proactive, positive, and professional culture within the Program Management Office. Mentor and coach junior Project Managers.Contribute to continuous improvement of PMO processes, related SOPs, and supporting tools.Education/Experience:
Bachelor’s degree in life sciences, engineering, or equivalent. PMP (Project Management Professional) certification strongly recommended.10 years industry experience; 5+ years in Project Management roles with increasing responsibilities.Experience working in an FDA regulated environment is required.Advanced understanding of design control quality standards and regulatory compliance requirements for medical device or diagnostics (ex. 510K submissions). Experience in developing Therapeutic Drug Monitoring (TDMs) Tests, Infectious Disease Tests, Toxicology Tests, QC Controls, or Companion Diagnostic test is preferred.Strong understanding of product development challenges and methods for resolution. High-level business acumen with experience using financial tools.Demonstrated skills using MS Project or related software for Project Management. Solid skills using MS Office, Outlook, Smartsheets, PPM Pro or other project management software.Non-Negotiable Hiring Criteria:
Solid ability to lead complex and virtual cross-functional project teams from feasibility to launch.Outstanding organizational skills with ability to multi-task and balance sophisticated and routine work activities.Demonstrated ability to lead, direct and manage cross-functional teams, influence business partners and get results through others. Strong conflict resolution skills.Excellent written and verbal communication skills with the ability to effectively communicate with team members, functional management, and senior leadership.
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