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.

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.

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.