Instrumentation Process Engineer

About Us
We are a fast-paced startup developing advanced molecular diagnostics technologies and are looking for a hands-on Instrumentation Process Engineer to help build, optimize, and scale the production of our electromechanical instruments.

The Role
This role is ideal for someone who thrives in ambiguity, enjoys wearing multiple hats, and wants to directly shape instrument assembly, calibration, testing, and manufacturing processes from early-stage development through production.
You will work closely with R&D, Quality, Operations, and contract manufacturers to improve instrument performance, reliability, manufacturability, and production consistency. This position combines hands-on instrument work with subsystem characterization, data analysis, technical documentation, and materials management.

Key Responsibilities
• Characterize and optimize thermal, optical, and mechanical subsystems to improve instrument performance, reliability, and consistency.
• Assemble, integrate, and test electromechanical instruments and subassemblies.
• Develop and execute instrument tuning and calibration procedures, documenting settings, methods, and acceptance criteria.
• Troubleshoot and repair instruments, perform root cause analysis, and verify the effectiveness of corrective actions.
• Develop and maintain manufacturing documentation, including assembly work instructions, test procedures, calibration records, and troubleshooting guides.
• Create, load, and maintain item records and bills of materials (BOMs) within product lifecycle management (PLM) or other controlled record systems.
• Manage inventory of components, subassemblies, instruments, and service parts to support development, production, and repair activities.
• Support the transfer of instrument designs from development to manufacturing, identifying opportunities to improve assembly, serviceability, and production scalability.

Qualifications
• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical field; equivalent relevant hands-on experience will also be considered.
• 3+ years of experience in instrumentation, manufacturing, process engineering, or a related technical role.
• Hands-on experience assembling, testing, calibrating, troubleshooting, or repairing electromechanical instruments.
• Working knowledge of thermal systems, optical components, and mechanical mechanisms.
• Ability to interpret engineering drawings, component specifications, wiring diagrams, and assembly documentation.
• Experience with item records, BOM management, inventory tracking, and controlled documentation.
• Familiarity with basic laboratory practices and measurement equipment.
• Ability to organize, analyze, and communicate findings from experimental and manufacturing datasets.

Key Attributes
• Independent working: Organizes priorities and completes work with limited supervision while recognizing when collaboration or escalation is needed.
• Critical thinking: Evaluates evidence, challenges assumptions, and makes sound technical decisions.
• Root cause analysis: Investigates underlying causes of instrument and process issues rather than addressing symptoms alone.
• Self-motivation: Takes initiative, follows through on commitments, and proactively identifies improvements.
• Clear communication: Documents work accurately and communicates effectively across technical teams, operations, and manufacturing partners.
• Systems thinking: Understands how subsystem interactions, assembly processes, calibration, and operating conditions affect overall instrument performance.
Preferred Skills
• Experience with PCR instruments, molecular diagnostics, life sciences tools, or analytical instrumentation.
• Familiarity with PLM, inventory management, and electronic quality management systems.
• Experience with equipment qualification, process validation, and risk management tools such as process failure mode and effects analysis (pFMEA).
• Familiarity with GMP, ISO 9001, ISO 13485, or similar quality frameworks.
• Experience with design of experiments, statistical analysis, or data-driven process optimization.
• Proficiency with spreadsheet-based analysis; familiarity with Python, MATLAB, or similar tools is a plus.