Senior Quality Engineer

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 Quality Engineer Reports to: QA Manager Location: Hybrid (Primary location: 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, regulatory, manufacturing, and external partners to help scale a novel drug-delivery platform that directly impacts patient experience and therapeutic success. This role will support quality processes for medical device development and manufacturing at Portal Instruments. The QE will represent Quality on internal and external project teams for both design and manufacturing. This role will support quality systems, document control, product design verification & validation, manufacturing process validation, customer feedback, and corrective and preventive action investigations and implementation. 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 Contribute directly to the development, validation, and commercialization of Portal’s drug-delivery platforms Collaborate across disciplines to solve complex technical and operational challenges and translate requirements into practical, compliant solutions Key Responsibilities Support new product development and product realization through all design control phases. Support verification & validation (test plans, protocols, reports), test method validation, incoming inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation, calibration and equipment validation

(IQ/OQ/PQ)

Support risk management file generation and maintenance for Portal Instruments products throughout their lifecycle. Collaborate with cross-functional teams on design and process related risk management activities. Administer Portal’s online document management system and oversee creation, issuance, maintenance, and retention of controlled documents and records Support origination and release of Engineering Change Orders Support continuous improvement of quality system procedures in accordance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971 Apply statistical methods and process design tools to establish test plans as well as evaluate test data and establish process control Lead or participate in corrective and preventive processes as required, including documentation of CAPA, root cause investigation, and implementation of improvement activities Conduct and/or participate in internal and external audits as needed Partner cross-functionally to translate quality requirements into practical, compliant solutions Act as subject matter expert for quality engineering practices Partner with Engineering and Operations to ensure designs are effectively transferred to manufacturing Engage with internal and external stakeholders, including vendors and partners Foster collaboration, cross-functional communication, and risk-based decision making What We’re Looking For Required Qualifications BS or MS degree in Engineering, Science, or related discipline 5+ years of quality engineering experience in the medical device, biotech, or pharmaceutical Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971 Knowledge of statistical sampling and data analysis methods using statistical software. Ability to work effectively in a fast paced, collaborative environment Strong communication skills and comfort working cross functionally Preferred Qualifications Experience with drug-device combination products and working knowledge of relevant standards (e.g. ISO 11608) Knowledge and experience with MDSAP, EU MDR, IEC 62304, and ISO 60601 Document Control experience in medical devices, biotech, or pharma Familiarity with electronic document control and PLM systems Experience supporting products through development, validation, and manufacturing transfer Experience working with contract manufacturers and establishing relationships with suppliers #J-18808-Ljbffr Portal Instruments