Lead Manufacturing Engineer

Nautilus Biotechnology•San Carlos, CA

About The Position

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines. We are hiring a strategic Lead/Principal Manufacturing Engineer to join our growing team. This person will architect and scale our internal production capability while integrating CMs for key assemblies. This is a foundational role: you will design the production architecture, establish operational patterns, and shape how manufacturing functions inside the company. Rather than maintaining an existing system, you’ll be building the engine — partnering closely with leadership, operating with high autonomy, and creating scalable systems that carry us from pilot builds through full production.

Requirements

10+ years in medical device, diagnostics, or regulated hardware environments.
Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Electrical Engineering, or a closely related technical field.
Proven experience:
Scaling from pilot/early-stage builds to commercial production.
Direct ownership of design transfer and transition from R&D to controlled manufacturing.
Experience establishing process validation strategy (IQ/OQ/PQ), PFMEA, traceability, and change control in regulated environments.
Led CMO technical transfer and supplier qualification strategy, not just vendor management.
Demonstrated ability to define manufacturing KPIs tied to business outcomes (COGS, margin, capacity, reliability).
Strong DFM/DFA and tolerance strategy experience.
Deep understanding of manufacturing test strategy and reliability methods.

Responsibilities

Define how manufacturing functions at Nautilus including; decision rights, validation philosophy, documentation rigor, CMO integration, and performance accountability. This role establishes the system, not just improves it.
Build the end-to-end production architecture (internal + CMO) before scale forces reactive fixes — including flow, test strategy, quality controls, traceability, and change management.
Anticipate scaling constraints, regulatory requirements, and cost inflection points 12–24 months ahead, and design infrastructure that prevents expensive retrofits.
Lead the shift from R&D-driven builds to controlled, validated production — embedding DFM, tolerance strategy, test coverage, and reliability thinking before release.
Shape our long-term COGS and margin profile through early architectural decisions — not late-stage cost-cutting.
Implement pragmatic but durable IQ/OQ/PQ, PFMEA, and traceability systems that enable RUO today without creating regulatory debt for tomorrow.
Architect technical transfer frameworks, qualification standards, and performance models that make external manufacturing predictable and scalable.
Define and instrument the KPIs that matter. Tie production performance directly to business metrics and use data to shape executive decisions.
Frame and resolve hard tradeoffs (speed vs. robustness, cost vs. reliability, centralization vs. outsourcing) with structured reasoning and executive influence.
Shift the company from “How do we build this unit?” to “How do we build a scalable manufacturing system?” Mentor engineers and raise the technical bar across functions.