Senior Program Manager

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.

Senior Program Manager

Report to:

SVP, Finance & Operations

Key Qualifications

7+ years of experience leading complex medical device or drug-device combination programs from concept through commercialization
Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or a related technical discipline (Master’s a plus)
Proven ability to lead cross-functional teams in a regulated environment, including R&D, Quality, Regulatory, Manufacturing, Clinical, Supply Chain, and external partners
Strong working knowledge of medical device development processes, design controls, and quality systems (21 CFR 820.30, ISO 13485)
Experience with risk management and relevant industry standards (ISO 14971; familiarity with ISO 11608 and ISO 11040 preferred)
Demonstrated success owning program scope, schedule, budget, risk, and resourcing while delivering against aggressive timelines
Experience supporting regulatory submissions and interactions (FDA 510(k), PMA, NDA, or combination product filings)
Excellent written and verbal communication skills, with the ability to provide clear, unbiased updates to senior leadership
Ability to operate effectively with limited direction in a fast-paced startup environment
Proficiency with project management tools such as MS Project and Smartsheet

Applicants are encouraged to review the full Job Description PDF for complete role details and responsibilities.

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Senior Program Manager

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Our values

Portal Instruments is committed to challenging implicit bias and creating an equitable work environment. We are proud to be an equal opportunity employer. All qualified candidates will receive consideration without regard to race, ethnicity or national origin, sexual orientation, gender identity or expression, genetics, military service, age, family status, or disability.

Senior Program Manager