Principal Mechanical Engineer

Sarmal Inc•San Diego, CA

7d•$165,000 - $200,000•Onsite

About The Position

We are seeking a Principal Mechanical Engineer to serve as instrument lead for our point-of-care molecular diagnostic platform, owning the mechanical and electromechanical architecture from concept through product launch. This is a hands-on senior individual contributor role. You will personally drive the design of both the instrument and its custom consumable, set the technical direction for outsourced design partners and contract development and manufacturing organizations (CDMOs), and establish the engineering practices that a growing internal hardware team will build on. The role operates with a high degree of independence, with the opportunity to scope and grow internal engineering capability as the platform matures. This is an on-site position based in San Diego, California.

Requirements

Proven track record of designing reliable electro-mechanical, fluidic, optical and thermal systems throughout the product development life cycle, from concept to product launch to sustaining support
Experience with designs for fluidically driven systems, preferably for microfluidic applications in the life science, molecular diagnostic, or point-of-care fields
Demonstrated experience designing or supporting custom consumables and their associated registration and alignment mechanisms
Working fluency across fluidic, optical, mechatronic, and electrical systems sufficient to own system-level architecture and integration decisions
Proven track record with design for manufacturability, with a working understanding of a variety of manufacturing processes including injection molding, machining, and automated assembly
Fluency in SolidWorks CAD, with strong command of GD&T and tolerance stack-up analysis
Strong collaboration skills and demonstrated experience directing vendors, outsource design partners, and CDMOs, with accountability for their technical deliverables
Comfort operating as a hands-on individual contributor in an early-stage environment, with the judgment to determine what to build internally versus outsource
Excellent written and oral communication skills

Nice To Haves

Experience applying FEA and CFD tools to thermal, fluid, and structural analysis
Experience developing medical devices or in vitro diagnostics under FDA design controls and ISO 13485, and/or familiarity with cGMP manufacturing environments
Experience with point-of-care or near-patient instrument constraints, including size, cost, usability, and robustness outside of a laboratory setting
Experience with nucleic acid amplification instrumentation (PCR or isothermal) or automated sample preparation
Experience with manufacturing systems and workflows, pilot production, and design transfer
Experience mentoring engineers or standing up an internal engineering function

Responsibilities

Translate assay, biological, and user requirements into robust mechanical and electromechanical hardware architectures; define product requirements and subsystem specifications for fluidics-based instrumentation.
Serve as the technical lead for instrument development from concept through design transfer, product launch, and sustaining support.
Lead and support the design and integration of fluidic components, motion and actuation systems, thermal modules, optical interfaces, and the mechatronic and electrical systems that tie them together.
Lead the design of custom consumables and disposable cartridges, including fluidic routing, valving, sealing, and the registration and alignment mechanisms that define the instrument-to-consumable interface.
Develop precise thermal modules for amplification and thermal cycling, heating and cooling management, and automated motion systems.
Perform hands-on design and build of breadboard systems, functional prototypes, and reliability test stations.
Apply analysis methods such as FEA, CFD, GD&T, and tolerance stack-up analysis to guide and de-risk designs.
Own and manage outsourced design partnerships, CDMOs, and key technology vendors, including scope definition, design reviews, milestone acceptance, and technical escalation.
Drive DFM and DFA across injection molding, machining, joining, and automated assembly processes, and support pilot builds and transfer to manufacturing.
Define and support design verification testing at the system and subsystem level, including reliability, durability, and environmental testing.
Author and maintain design inputs and outputs, risk analyses, and design history file content as the platform advances from research use toward a regulated in vitro diagnostic product.
Drive alignment with molecular biology, assay development, software, and manufacturing counterparts; mentor engineers and help define the internal hardware function as the team grows.