Hiring: Project Manager II Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-16 10:18:47 Employment Type: Hybrid Target Skills & Keywords : Agile, Asana, Jira, Salesforce About the job Experience: •5+ years of Project Management specific experience Required Skills: •Own end-to-end project delivery by leading projects from initiation through hypercare, including charter development, business case alignment, vendor selection, build, test, validation, deployment, and stabilization. •Coordinate multiple workstreams across functional, technical, validation, change management, and training areas within a single project. May provide direction to one or more Project Manager I peers. •Drive vendor and SOW execution by leading vendor selection processes, supporting SOW negotiations with Legal and Procurement, and managing vendor delivery against contractual commitments. Maintain executive-level vendor relationships. •Manage the GxP validation lifecycle for assigned systems, including User Requirements, Functional Requirements, IQ/OQ/PQ protocols, Validation Summary Reports, and inspection-ready documentation. Coordinate closely with Quality and Validation leads. •Support cross-functional decision-making by preparing steering committee materials, running design alignment workshops, and structuring decision packages with clear options, recommendations, and trade-offs. Maintain decision logs that can support audit and inspection needs. •Identify and manage program-level risks beyond the immediate project scope. Build mitigation plans with named owners and trigger criteria, and escalate to PMO leadership with proposed solutions. •Own project financial management, including budget, forecast, and actuals. Manage CapEx and OpEx categorization, track consulting hours, validate invoices against SOW deliverables, and report variance to PMO leadership and Finance. •Mentor and support Project Manager I peers by providing informal coaching on PMO methodology, AI tool adoption, and stakeholder management. Contribute to the PMO knowledge base and template library. Qualifications: •Bachelor’s degree in business, engineering, life sciences, IT, or a related field required; equivalent experience will be considered. Advanced degree such as MBA, MS, or MEng is strongly preferred. •Demonstrated track record of leading projects end-to-end in a professional setting, including budget ownership, vendor management, and executive communication. •Working fluency with project management methodologies, including Waterfall, Agile, and hybrid approaches, with the ability to apply the right methodology based on business context. •Solid functional working knowledge of GxP concepts, including CSV, Computer System Validation, change control, deviation management, and CAPA processes. •PMP certification, certification in progress, or equivalent demonstrated mastery such as CSM, PgMP, PRINCE2, or comparable experience. •Strong AI-enabled project management practice, with the ability to walk through specific examples of how AI has improved project delivery, including tool choices, prompt design, validation steps, and lessons learned. •Excellent written and verbal communication skills, including direct interaction with executive stakeholders at the Director level and above. •Operational familiarity with enterprise platforms such as SAP, Salesforce, or equivalent systems, particularly in the context of implementation programs. •Preferred experience includes direct medical device industry experience with FDA / EU MDR submission familiarity, fluency with Smartsheet, Jira, MS Project, or Asana, and Six Sigma Green Belt, Lean, or business process improvement certifications. •Comfort with working at a computer for extended periods. Compensation: •$110,000 - $130,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!