Senior Systems Engineer

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. The Senior Systems Engineer will support the SW, Electrical Engineering, and Mechanical Engineering teams with designing, building, documenting and testing software controlled electromechanical systems.

Senior Systems Engineer

Report to:

VP of Engineering

What You’ll Do

Your Impact

• Work closely with software, electrical and mechanical engineers to design, build, document and test electronics systems for next generation electromechanical autoinjectors and related test setups

• Evaluate component and system performance by developing, executing, and documenting verification and validation plans.Evaluate the feasibility of meeting external partner needs.

• Collaborate with cross-functional engineering and manufacturing teams to meet product launch goals

Key Responsibilities

· Partner cross‑functionally to translate requirements into practical, compliantsolutions

· Support MRD /PRD development, documentation and lifecycle management

· Support RiskManagement documentation (RMF workbook, dFMEAs, pFMEAs, uFMEA) development

· Evaluate component and system performance by developing, executing, and documentingverification and validation plans

· ReliabilityEngineering / test fixture / test plan development

· Engage with internal and external stakeholders, including vendors and partners

What We’re Looking For

Required Qualifications

· Experience with interdisciplinary engineering with a degree related to Mechanical,Electrical, or Software Engineering.

· 5+ years of experience in medical devices, biotech, pharma, or a regulated industry

· Experience working within quality systems (e.g., ISO 13485, design controls)

· Ability to work effectively in a fast paced, collaborative environment

· Experience with soldering, test, measurement setup and basic lab equipment (oscilloscope,DMM, DAQ, etc.)

· Experience with mechanical fabrication for prototypes: machining, and 3D printing

· Proven analytical, reporting, and documentation skills

· Familiarity with ECAD tools such as Altium for schematic capture and PCB layout

· Familiarity with CAD tools such as Solidworks for mechanical design

· Experience with microelectronics and embedded systems

· Experience programming in Python, C and C++

· Experience automating test setups and data acquisition.

Preferred Qualifications

· Experience with drug-device combination products

· Exposure to human factors engineering, usability, or patient centric design

· Experience supporting products through development, validation, or commercialization

Strong communication skills and comfort working cross functionally

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Senior Systems Engineer

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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 Systems Engineer