Principal Mechanical Engineer

About the role

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.

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
• 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

Benefits

• Medical, dental, and vision coverage
• Company-paid life insurance
• 401(k) retirement plan
• Generous paid time off
• Access to additional voluntary benefits, employee perks, and discount programs
• We are committed to supporting the well-being of our employees and providing a strong foundation for both professional and personal success.
• Dental
• Vision
• 401(k)
• PTO