Job Description

Process Engineer - Ultrasound Manufacturing

Location: Markham, Ontario (Onsite) o Employment Type: Full-Time

About Sonele Inc.

Sonele Inc. is a Canadian medical technology company specializing in the design, development, and manufacturing of advanced ultrasound transducers and related electronic systems. We combine acoustic R&D with precision manufacturing under an ISO 13485 quality system to support medical and industrial applications.

Role Summary

The Process Engineer supports transfer from prototype to production for ultrasound transducers. The role focuses on building, documenting, and sustaining robust manufacturing processes (dicing, lapping, bonding/adhesive assembly, micro-assembly) while collaborating closely with R&D, manufacturing, quality, and operations.

Key Responsibilities

Translate prototype designs into manufacturable processes; develop travelers, work instructions, and process maps.

Establish equipment parameters and maintenance routines for precision/subtractive manufacturing (e.g., dicing, CNC micromachining) to ensure repeatability and yield.

Conduct DOEs, capability studies, and SPC to drive data-based improvements; support root cause analysis and corrective/preventive actions (CAPA).

Qualify materials, tooling, and suppliers; collaborate on fixturing/tolerancing for manufacturability.

Support pilot builds, process validations (IQ/OQ/PQ), and documentation aligned to ISO 13485 and applicable regulatory expectations.

Partner with Quality to improve cycle time, yield, and cost through continuous improvement and lean practices.

Qualifications

Bachelor's degree in Mechanical, Manufacturing, Industrial, or Materials Engineering (or related).

~3+ years' experience in process/manufacturing engineering within a precision, regulated, or high-documentation environment (medical devices, semiconductor, aerospace, etc.).

Hands-on experience with precision/subtractive processes (dicing, milling, drilling), adhesives/epoxies, and micro-assembly.

Working knowledge of DOE/SPC and statistical analysis tools (e.g., Minitab/JMP).

Familiarity with ERP/MES, PFMEA, and DFM principles.

Strong communication, organization, and troubleshooting skills.

Why Join Sonele

Structured, high-precision environment with end-to-end ownership from R&D through production, and the opportunity to scale processes for next-generation ultrasound products.

The above information on this job description and specification has been designed to indicate the general nature and level of work performed by employees within this job. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.