About Microvitality
Microvitality is a Tufts University spinout reimagining how we understand the human gut. We are developing an ingestible, pH-responsive capsule that enables precise, non-invasive, and contamination-free sampling of the small intestine microbiome, a region of the gastrointestinal (GI) tract that is clinically critical yet virtually inaccessible without invasive procedures.
Our first clinical indication is Small Intestinal Bacterial Overgrowth (SIBO), with Irritable Bowel Syndrome (IBS) and Celiac Disease on our near-term roadmap.
Microvitality is a small, pre-seed stage, high-conviction team operating at the intersection of biomedical engineering, GI diagnostics, and microbiome science. We move fast, think rigorously, and care deeply about the patients we ultimately serve.
The Opportunity
This is a rare founding-team opportunity for a technically exceptional builder who wants to own the full technology stack of a medical device from prototype to clinical deployment. As Founding Principal Engineer, you will be the primary technical architect of the Microvitality capsule, responsible for hardware design, materials selection, manufacturing strategy, sensing integration, and the analytical workflows that transform raw biological samples into actionable clinical insights.
You will work directly with the founding team, our advisors, mentors, and clinical partners around the world. This is not a role for someone who prefers to manage at a distance, we need someone equally comfortable at the bench, inside a computer-aided design (CAD) tooling, and in front of investors presenting technical strategy.
Key Responsibilities
Device Design & Engineering
- Lead parametric CAD design and iterative prototyping of the Microvitality ingestible capsule, including pH-responsive coating architecture, internal sampling mechanics, and capsule retention features.
- Take initiative writing standard operating procedures (SOPs) and design drafts including technical files.
- Drive materials selection and coating process development — including enteric polymer systems (e.g., Eudragit L100) and dual-coating strategies optimized for small intestinal targeting.
- Oversee manufacturing process selection and development, injection molding pathways, and hybrid manufacturing strategies to support prototype-phase and scale-up production.
- Maintain rigorous version-controlled design documentation.
- Maintain full traceability of all materials and components used to manufacture the Microvitality ingestible capsule.
Sensing & Analytical Integration
- Evaluate and integrate sensing modalities into the capsule platform (e.g., pH, pressure, optical) to enable real-time or post-retrieval diagnostic data.
- Develop and refine the downstream biological sample analysis workflow, including 16S rRNA amplicon sequencing (V4 region), Illumina MiSeq processing, mothur-based bioinformatics pipelines, and qPCR validation.
- Assess integration feasibility of emerging multi-omics approaches (metagenomics, metabolomics, proteomics) for future capsule generations.
Testing, Validation & Regulatory
- Oversee the creation and implementation of a quality system compliant with FDA 21 CFR Part 820/ISO 13485.
- Design and execute in vitro, ex vivo, and in vivo testing protocols to demonstrate capsule safety, targeting precision, sample integrity, and diagnostic performance.
- Build and maintain a design history file (DHF) aligned with FDA 21 CFR Part 820 / ISO 13485.
- Collaborate with regulatory counsel and clinical partners on MHRA (UK) and FDA submissions, including Investigational Device Exemption (IDE) documentation and Non-Significant Risk maintenance.
- Support first-in-human (FIH) study design at The Functional Gut Clinic (UK), including capsule preparation protocols, collection kit specifications, and safety monitoring criteria.
R&D Strategy & Leadership
- Define and execute the multi-generation technology roadmap — from SIBO diagnostics to IBS, Celiac Disease, and beyond.
- Identify and manage relationships with academic collaborators, Contract/Clinical Research Organizations (CROs), and manufacturing partners.
- Represent Microvitality's technical platform in investor diligence, grant applications, and scientific publications.
- Recruit, manage, and mentor junior engineers and research interns; build a culture of rigorous, mission-driven engineering.
- Protect and expand Microvitality's intellectual property (IP) portfolio, including patents, trade secrets, and proprietary process know-how.
Qualifications & Experience
Required
- M.S. or Ph.D. in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a closely related field.
- 5+ years of hands-on experience in medical device R&D, with demonstrated work on ingestible, implantable, or minimally invasive devices.
- 5+ years of experience building, managing, directing, and retaining interdisciplinary teams in a start-up environment.
- Deep expertise in at least two of: CAD/parametric modeling, additive manufacturing, materials science, sensor integration, software-controlled electromechanical devices, or microfluidics.
- Direct experience with Class II medical devices, interacting with FDA and/or MHRA regulatory frameworks (510(k), De Novo, PMA, or IDE pathways).
- Proven ability to operate in a fast-moving startup environment, taking initiative and providing results with limited resources.
- Strong written and verbal communication skills, including translating technical complexity for non-technical investors and clinical partners.
Strongly Preferred
- Experience with enteric coating systems or controlled-release drug/device formulations
- Capsule hardware design and iterative prototyping (i.e., Stereolithography 3D printing/SLA, Fused Deposition Modeling/FDM, CAD, STEP-to-print workflow).
- Familiarity with microbiome sequencing workflows (16S rRNA, shotgun metagenomics) and bioinformatics tools (mothur, QIIME2, DADA2).
- Prior work on GI diagnostics, capsule endoscopy, or ingestible sensor platforms.
- Experience building or managing ISO 13485-compliant quality management systems
- ISO 14971, risk management.
- Track record of filing or contributing to patents in medical devices or life sciences.
- Previous experience at an early-stage medtech or biotech startup (pre-seed through Series A).
Pay: $87,510.28 - $105,388.73 per year
Benefits:
Work Location: Hybrid remote in Cambridge, MA 02139
