Medical Device Systems Engineer

Medical Device Systems Engineer

Position Summary

PASCALL is seeking a Medical Device Systems Engineer to join our team and contribute across a wide range of engineering functions. This is a high-ownership, generalist engineering role at an early-stage medical device startup — designed for someone who learns fast, thinks systematically, and can apply strong analytical instincts across hardware, software, and quality domains.

You will work closely with our lead hardware engineer, sharing the load on vendor relationship management, hardware development and testing, and quality-related activities as the team scales. You will also serve as a technical bridge to our software development resources, helping raise the quality bar on software processes. At PASCALL, strong engineers take on broad responsibility quickly — this role is designed for someone who wants that kind of ownership from day one.

PASCALL actively uses agentic AI tools to accelerate development, documentation, and engineering workflows. We welcome engineers who are comfortable experimenting with AI-assisted workflows and applying them responsibly in a regulated environment.

Responsibilities

Hardware Development & Testing

• Support electronics testing, characterization, and validation using bench instrumentation including physiological signal simulators
• Contribute to experimental design, data collection, and analysis across hardware development and verification activities
• Assist with PCB bring-up, component evaluation, and conformance/non-conformance testing
• Maintain technical documentation consistent with ISO 13485 design history file requirements

Software Quality & Engineering Support

• Engage with PASCALL’s software development process to identify quality gaps and support improvement initiatives
• Contribute to software testing, documentation review, and validation activities for our Android-based clinical application
• Write scripts and tooling to support test automation, data analysis, or workflow improvement
• Serve as a technical bridge between the hardware team and software development resources

Vendor Coordination & Supply Chain

• Co-manage third-party vendor relationships including mechanical engineering, electrode/adhesive patch development, and test houses
• Assist with incoming quality testing, component acceptance criteria, and vendor review cycles
• Help define and track technical requirements for outsourced components

AI-Augmented Development

• Use AI-assisted tools (e.g., LLM-powered coding assistants, automated documentation) to accelerate development tasks
• Apply AI tools responsibly within PASCALL’s regulated development environment

Qualifications

Education

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Computer Engineering, or a closely related field

Experience and Skills

• Strong analytical and problem-solving skills — comfortable working with data, designing experiments, and drawing conclusions from test results
• Some experience or coursework in software development, including scripting, automation, or application-level work
• Ability to learn quickly across technical domains and take ownership of tasks outside your core background
• Meticulous attention to detail; able to produce clear, accurate technical documentation
• Comfortable working across internal teams and with external vendors and consultants
• 0–3 years of experience; we actively welcome strong recent graduates
• Comfort using AI-assisted tools (e.g., GitHub Copilot, Claude, ChatGPT, Cursor) for engineering, documentation, or analysis

Technical Background (Preferred)

• Hands-on experience with electronics testing, bench instrumentation, or PCB-level debugging
• Familiarity with software quality practices — testing, documentation, or validation in a development environment
• Exposure to ISO 13485, FDA design controls, or other regulated development frameworks
• Experience with signal processing, physiological data analysis, or wearable sensor systems

About PASCALL Systems

PASCALL is a Cambridge-based medical device company focused on advancing neuroscience-based personalized anesthesia monitoring. Our team includes leading academic and clinical experts from MIT, Harvard, Stanford, and Massachusetts General Hospital.

We achieved ISO 13485 certification for medical device design and development and received FDA 510(k) clearance for our first platform device in 2022. We are now building the next generation of EEG-based brain state algorithms to improve anesthesia care and patient outcomes worldwide.

Our vision is to bring personalized, science-based anesthesia care to all patients.

How to Apply

Only candidates who submit a Cover Letter addressing all of the following questions will be considered:

• What excites you about this role and PASCALL’s mission?
• Describe a project where you had to quickly develop expertise in an unfamiliar technical area — what was your approach and what did you learn?

Details

Pay: $75,000 - $105,000 per year

Work Location: In person — Cambridge, MA

Job Type: Full-time

Pay: $75,000.00 - $105,000.00 per year

Work Location: In person