Staff NPI / Industrialization Engineer
$130k - $160kPortal Instruments
About Portal Instruments Portal Instruments is redefining how advanced injectable therapies are delivered. Founded on MIT research, we are building a next-generation drug delivery platform that enables high- volume, high-viscosity biologics to move from IV infusion to subcutaneous injection, unlocking a new generation of at-home therapies. Our lead platform, PRIME Nexus™, combines reusable hardware with software-tunable delivery to enable therapies that were previously not feasible outside the clinic. We have secured development partnerships with leading biotech companies and are now entering the most critical phase of the company: scaling from advanced engineering to clinical-ready and manufacturable systems Role Information Title: Staff NPI / Industrialization Engineer Reports to: VP, Engineering Location: Boston/Cambridge, MA (on-site presence required) 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 ensure that Portal’s designs translate into scalable, manufacturable products. Embedded within the engineering team, this role brings manufacturing, industrialization, and assembly into considerations into the design process from the earliest stage. As Staff NPI Engineer you will design, build, test, and improve mechanical and electromechanical devices, equipment, and systems made by Portal Instruments for manufacturing and assembly. You will also design and build test and assembly fixtures for use in verification and manufacturing assemblies of drug delivery systems. You will partner closely with design engineering and the Head of Industrialization to ensure that what is designed can be built, scaled, and delivered reliably. The goal of your work will be to eliminate late-stage surprises and accelerate the path to clinical and commercial readiness. This role is critical to eliminating the traditional “design-to-manufacturing gap” and enabling a tightly integrated development and industrialization process. T. View phone number on click.appcast.io E. View email address on click.appcast.io 190 Fifth Street, Cambridge, MA 02141 What You’ll Do Your Role in our Operating Model
- Embedded within engineering, reporting to VP Engineering
- Partners closely with Industrialization / Manufacturing leadership
- Responsible for integrating manufacturability, assembly, and test considerations into product
- Acts as a bridge between design engineering and manufacturing execution
- Provides early validation of design decisions against manufacturing and scalability constraints
- Collaborate across disciplines to solve complex technical and operational challenges
- Help ensure solutions are scalable, compliant, and grounded in real-world use
- Evaluate and challenge designs for manufacturability, scalability, and assembly efficiency
- Identify and mitigate manufacturing risks early in development
- Collaborate with industrialization and external manufacturing partners (e.g., CDMOs) to ensure
- Support design transfer by validating build readiness and resolving manufacturability gaps
- Partner with industrialization and manufacturing teams to ensure designs are ready for transfer
- Design, build, and debug experimental test instrumentation
- Design and implement test methods for analysis and characterization of electro-mechanical
- Design and implement device assembly work instructions and procedures
- Perform all duties in compliance with Portal’s quality system regulations and GLP standards
- 6 years of experience in medical devices, biotech, pharma, or a regulated industry
- Proficiency in SolidWorks
- Experience working within quality systems (e.g., ISO 13485, design controls)
- Ability to work effectively in a fast-paced, collaborative environment
- Experience bridging engineering and manufacturing in NPI or industrialization roles
- Experience working with external manufacturing partners / CDMOs
- Demonstrated ability to influence design decisions based on manufacturability
- Experience in data analysis tools, such as MATLAB and Minitab
- Machining experience such as manual machine tools and CNC machining
- 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
- 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
- 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
- 20 days of vacation annually (encouraged to use)
- 13 company observed holidays
- Periodic company-wide holiday shutdowns
- Sick time separate from vacation
- 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
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