Director, Integrated PMO - Medical Devices & Diagnostics

SiPhox Health; Burlington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

SiPhox Health is seeking a seasoned PMO Lead to own the integrated product program spanning hardware, software, QC, regulatory, and manufacturing, with accountability for the full lifecycle from development to launch.

You will translate objectives into executable workstreams with defined owners, drive weekly reviews, manage risks, and maintain a single source of truth for progress, ensuring on-time delivery in a fast-growing diagnostics startup environment.

Qualifications

• 10+ years of program or project leadership in medical devices, diagnostics, life sciences, complex hardware, or another regulated multidisciplinary product environment.
• Demonstrated ownership of a complex product-development program spanning hardware, software, science, V&V, manufacturing, quality, and regulatory activities.
• Strong command of integrated scheduling, dependency management, critical-path analysis, risk management, resource planning, and change control.
• Working knowledge of design controls, verification and validation, design transfer, regulated documentation, and quality-system expectations.
• Ability to understand technical detail across disciplines, ask incisive questions, identify hidden dependencies, and distinguish evidence from optimism.
• Exceptional follow-through and written and verbal communication; able to turn ambiguity into clear ownership and executable plans.
• Comfort operating in a fast-growing environment where systems are still being built and priorities must be translated into disciplined execution.
• Bachelor’s degree in engineering, science, operations, or a related field; advanced technical or business degree is a plus.

Responsibilities

• Build and maintain the integrated master plan from development through design freeze, V&V, clinical studies, submission, clearance readiness, manufacturing scale-up, and launch.
• Translate company objectives into executable workstreams, milestones, deliverables, owners, dependencies, resource needs, decision points, and acceptance criteria.
• Establish and enforce a practical PMO framework that gives leadership accurate visibility without creating unnecessary bureaucracy.
• Maintain the authoritative view of program status, critical path, schedule confidence, resource constraints, and tradeoffs.
• Coordinate hardware, systems engineering, consumables, assay development, surface chemistry, critical reagents, software, data science, V&V, quality, regulatory, clinical, manufacturing, facilities, and supply chain.
• Drive handoffs and interface decisions between teams—for example, assay requirements into cartridge and instrument specifications, design outputs into manufacturing processes, and product requirements into verification evidence.
• Ensure workstream plans are mutually consistent and that upstream delays or changes are reflected immediately in downstream plans.
• Surface gaps in ownership, requirements, staffing, equipment, vendors, samples, materials, and documentation before they affect the critical path.
• Partner with functional owners to translate the V&V strategy into a resource-loaded execution plan covering protocols, test articles, instruments, lots, sites, samples, operators, data review, deviations, and reports.
• Coordinate design-control deliverables and readiness reviews, including requirements, risk management, traceability, verification, validation, design transfer, and submission inputs.
• Track evidence completeness and ensure dependencies between technical work, controlled documentation, and regulatory milestones are explicit.
• Drive timely resolution of deviations, failed tests, CAPAs, design changes, and other issues that threaten program objectives.
• Integrate manufacturing process development, equipment commissioning, supplier qualification, incoming materials, pilot builds, lot planning, QC, release, yield improvement, capacity, and design transfer into the master program.
• Coordinate build plans for instruments, cartridges, reagents, controls, calibrators, and study materials, with clear quantities, timing, yield assumptions, and contingency stock.
• Partner with operations and technical leaders to identify capacity constraints and make-versus-buy, supplier, tooling, automation, and capital-equipment decisions on time.
• Track long-lead items and supplier risks and ensure mitigation plans have owners and trigger dates.
• Run weekly program reviews, workstream reviews, milestone-readiness reviews, and executive decision forums with clear agendas, pre-reads, decisions, owners, and follow-through.
• Maintain decision, risk, issue, action, assumption, and change logs; define escalation thresholds and elevate early with options and recommendations.
• Create concise executive and board-level reporting focused on outcomes, critical path, schedule confidence, resource needs, and decisions—not activity summaries.
• Institute disciplined change control so changes in scope, requirements, sequencing, or resources have visible consequences and authorized decisions.

Skills

Program leadership

Cross-functional leadership

Scheduling

Risk management

Change control

Executive communication

Education

Bachelor’s degree in engineering, science, operations, or related field

Job description

SiPhox Health is seeking a seasoned PMO Lead to own the integrated product program spanning hardware, software, QC, regulatory, and manufacturing, with accountability for the full lifecycle from development to launch.

You will translate objectives into executable workstreams with defined owners, drive weekly reviews, manage risks, and maintain a single source of truth for progress, ensuring on-time delivery in a fast-growing diagnostics startup environment.