Senior Program Manager

About Portal Instruments

Portal Instruments is redefining how advanced injectable therapies are delivered.

Founded on MIT research, Portal develops innovative drug-delivery platforms that enable patients to self-administer complex biologics safely, comfortably, and reliably. Our lead platform, PRIME Nexus®, is a reusable, software-tunable drug-delivery system designed to support high-viscosity and large-volume injectables, with both needle-assisted and needle-free delivery options depending on therapeutic needs.

Portal partners with biopharmaceutical companies and key players in the medical device ecosystem to integrate our delivery platforms into drug–device combination products that improve patient experience, reduce cost of goods, and support successful commercialization. Guided by human-factors science, rigorous engineering, and real-world usability, Portal is building the next generation of patient-centric drug delivery solutions.

Role Information

Title: Senior Program Manager

Reports to: SVP, Finance & Operations

Location: On-Site Boston/Cambridge, MA

Position Overview

This role is a critical part of Portal’s mission to advance PRIME Nexus® toward commercialization. You will work cross-functionally with engineering, quality, regulatory, manufacturing, and external partners to help scale a novel drug-delivery platform that directly impacts patient experience and therapeutic success.

This is an opportunity to take ownership, solve complex problems, and contribute meaningfully at a pivotal stage of Portal’s growth.

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

Working at Portal Instruments

Portal offers the opportunity to work on meaningful technology with real patient impact, alongside a highly collaborative and mission-driven team. We value innovation, accountability, transparency, and

thoughtful problem-solving—and we believe great work happens when people feel supported and empowered.

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.

Benefits & Perks

Health & Wellness

•  Medical plan options including PPO HSA and HMO HSA eligible plans

• Competitive dental, orthodontic, vision, and accident insurance

• Flexible Spending Accounts (medical, dependent care, commuter)

• Employee Assistance Program with counseling, financial tools, and legal resources

Financial & Protection

• Stock options

• 401(k) with Roth and traditional options

• 100% company-paid short- and long-term disability

• Company paid life and AD&D insurance

• Paid Family and Medical Leave

Rest & Recharge

• 20 days of vacation annually (encouraged to use)

• 13 company observed holidays

• Periodic company-wide holiday shutdowns

• Sick time separate from vacation

Additional Perks

•  Daily lunch (Cambridge office)

• Casual dress code

• On site bike room, lockers, and showers (subject to availability)

• Happy hours and company sponsored events

• Annual volunteer opportunities and donation match program

Inclusion & Equal Opportunity

At Portal, we believe all employees should feel they belong, contribute, and thrive. We know that diverse teams create better solutions for diverse patients, and we encourage applicants from all

backgrounds to apply.

Portal Instruments is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity or national origin, sexual orientation, gender identity or expression, genetics, military service, age, family status, or disability.

How to Apply

Please submit a resume (and cover letter if applicable) to [email protected]. Candidates will be contacted if their background aligns with Portal's needs.