Director, Program Management

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 building an integrated diagnostic platform that combines advanced hardware, silicon photonics, microfluidics, assay science, software, and scalable cartridge manufacturing. We are seeking a highly capable program leader to build and run the operating system that turns these interdependent workstreams into reliable, on-time execution.

This is not a narrow project-management or meeting-coordination role. You will own the integrated company program across hardware development, assay and reagent development, verification and validation, software, manufacturing, supply chain, quality, regulatory readiness, clinical execution, and product launch. You will know what must happen, by whom, by when, what is at risk, and what decisions are required to keep the program moving.

Create a single, rigorous source of truth for the product program and drive the organization from plans to completed, documented outcomes. Functional leaders retain ownership of technical content and technical decisions; the PMO Lead owns cross-functional integration, commitments, dependencies, operating cadence, escalation, and execution discipline.

What you will own

Integrated program leadership

• 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.

Cross-functional execution

• 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.

V&V, quality, and regulatory readiness

• 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.

Manufacturing and supply readiness

• 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.

Program controls and executive communication

• 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.

What success looks like

• One integrated plan is trusted and used by every function; separate plans reconcile to it.
• The critical path, near-term deliverables, and top risks are visible and current at all times.
• Teams leave reviews with clear decisions, owners, due dates, and acceptance criteria—and commitments reliably close.
• V&V, clinical, manufacturing, and regulatory activities begin with the required people, materials, equipment, protocols, and documentation ready.
• Schedule slips and resource conflicts are identified early enough for leadership to act, rather than discovered at milestone dates.
• Leadership spends less time reconstructing status and more time making high-quality decisions.

First 90 days

• Days 1–30: Map every active workstream, owner, milestone, dependency, resource constraint, and major risk; establish the baseline integrated plan and reporting cadence.
• Days 31–60: Stabilize workstream plans, critical-path logic, readiness criteria, risk escalation, decision tracking, and cross-functional handoffs; resolve the highest-impact planning gaps.
• Days 61–90: Operate the full PMO cadence, deliver a leadership-approved program baseline, and demonstrate improved predictability, issue closure, and milestone readiness.

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.

The person who will thrive in this role

You are technically curious, operationally rigorous, calm under pressure, and willing to challenge unclear ownership or unrealistic commitments. You earn trust with functional experts without pretending to replace them. You can move fluidly between a detailed build plan, a V&V readiness review, a supplier constraint, and an executive discussion—and leave each with greater clarity and momentum. You are persistent without being bureaucratic and direct without creating friction.

Working relationships

This role reports to the CTO and works closely with the CEO and leaders across Science, Assay Development, V&V and Quality Control, Assay Chemistry and Reagent Manufacturing, Hardware, Software, Quality, Regulatory, Clinical, Operations, Manufacturing, and Supply Chain. The role may build and lead a small PMO team as company needs grow.

Why SiPhox Health

SiPhox Health is working to make high-quality health information more accessible by bringing sophisticated diagnostic testing closer to the individual. This role sits at the center of that mission: converting ambitious science and engineering into a validated, manufacturable, and launch-ready product.