Senior Program Manager

What You’ll Do

Your Impact

_{· Lead the development, regulatory approval, and commercialization of Portal’s PRIME Nexus® drug-delivery platform}

_{· Enable cross-functional teams to deliver a complex medical device on time, on budget, and in compliance with quality and regulatory requirements}

_{· Act as a thought partner to senior leadership to improve execution, processes, and program rigor}

Key Responsibilities

·      Own overall program planning and execution, including scope, schedule, budget, risk management, and resourcing

·      Lead cross-functional teams spanning R&D, quality, regulatory, clinical, manufacturing, supply chain, marketing, and external vendors

·      Develop and maintain detailed project plans, milestones, dependencies, and critical paths

·      Track project deliverables and drive tactical execution to maintain program timelines

·      Identify, assess, and proactively escalate program risks, issues, and decision points

·      Ensure compliance with design control requirements and lead teams through a phase-gate development process

·      Provide clear, unbiased program updates to cross-functional stakeholders and senior leadership

·      Establish and maintain project tracking tools, metrics, and dashboards to monitor progress and resource needs

·      Schedule and facilitate team meetings, design reviews, and management updates; set agendas and document decisions and action items

·      Coordinate and track deliverables from external vendors and service providers

·      Lead or participate in root-cause investigations and corrective/preventive action initiatives

·       Drive continuous improvement in program management tools, frameworks, and best practices

What We’re Looking For

Required Qualifications

·      Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related technical discipline

·      7+ years of industry experience in medical device, combination product, or drug product development (or 5+ years with a Master’s degree)

·      Proven experience delivering complex medical devices from concept through commercialization

·      Strong knowledge of medical device development processes and regulatory requirements

·      Demonstrated ability to lead cross-functional teams in a regulated environment

·      Experience working within design controls and quality systems (21 CFR 820.30, ISO 13485)

·      Familiarity with risk management standards (ISO 14971) and related industry standards (e.g., ISO 11608, ISO 11040)

·      Excellent written and verbal communication skills

·      Ability to operate effectively with limited direction in a fast-paced startup environment

·      Experience using project management tools such as MS Project and Smartsheet

Preferred Qualifications

·      Experience leading drug-device combination product development

·      Direct experience supporting FDA submissions (510(k), PMA, NDA, or combination product filings)

·      Hands-on experience applying ISO 14971 (risk file ownership, FMEA facilitation)

·      Deep familiarity with drug-delivery system standards (e.g., ISO 11608, ISO 11040)

·      Experience coordinating external vendors, CMOs, or development partners

·      Background supporting verification, validation, and market launch activities

·      Comfort acting as a thought partner to senior leadership on process improvement and execution rigor

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Compensation

Salary Range (Massachusetts):

The expected base salary range for this role in Massachusetts is $150,000 – $170,000, subject to confirmation with HR based on market benchmarking and internal equity.

Compensation for candidates in other U.S. locations may vary based on geographic market factors.This role may also be eligible for additional compensation and benefits.