Project Manager II (AI)

TL;DR

Project Manager II (AI): Leading end-to-end cross-functional projects, including GxP-validated systems and enterprise implementations, with an accent on AI-enabled analysis, regulated delivery, and executive decision support. Focus on managing validation lifecycles, vendor commitments, project finances, and complex risks across medical device and life sciences initiatives.

Location: Hybrid work schedule in Waltham, Massachusetts, with onsite work Monday through Thursday.

Salary: $91,000–$121,000 per year.

Company

hirify.global develops scientific, analytical, biotechnology, and in vitro diagnostic instrumentation for bioprocessing and clinical markets.

What you will do

• Lead projects from initiation through deployment, validation, hypercare, and stabilization.
• Coordinate functional, technical, validation, change management, and training workstreams.
• Manage vendor selection, statements of work, contractual delivery, and executive-level relationships.
• Own GxP validation activities and inspection-ready documentation in partnership with Quality and Regulatory Affairs.
• Prepare steering committee materials, facilitate design workshops, and structure decision packages with options, recommendations, and trade-offs.
• Manage budgets, forecasts, actuals, CapEx and OpEx, risks, invoices, and project reporting while mentoring Project Manager I peers.

Requirements

• Bachelor’s degree in business, engineering, life sciences, IT, or a related field, or equivalent experience.
• Demonstrated experience leading projects end-to-end with budget ownership, vendor management, and executive communication.
• Fluency in Waterfall, Agile, and hybrid project management methodologies.
• Experience in a regulated industry, with medical device, biotech, pharmaceutical, clinical, laboratory, or IVD experience preferred.
• Working knowledge of GxP, CSV, computer system validation, change control, deviation management, CAPA, and relevant standards including FDA 21 CFR Part 11, ISO 13485, IEC 62304, and EU MDR.
• Strong AI-enabled project management practice, including tool selection, prompt design, validation, and application to delivery analysis.

Nice to have

• MBA, MS, MEng, PMP, CSM, PgMP, PRINCE2, or equivalent certification.
• Experience with SAP, Salesforce, Smartsheet, Jira, MS Project, or Asana.
• Medical device submission experience and familiarity with FDA and EU MDR requirements.
• Six Sigma Green Belt, Lean, or business process improvement certification.

Culture & Benefits

• Hybrid and flexible work arrangements with a collaborative, empowered culture.
• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Office lunch and snack marketplace or subsidized cafeteria at selected Massachusetts and Maine locations.