Job Description

Senior Process Engineer - Ultrasound Manufacturing

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

About Sonele Inc.

Sonele Inc. is building Canada's hub for ultrasound innovation, uniting advanced transducer R&D with vertically integrated manufacturing. We operate under ISO 13485 and collaborate across acoustic design, materials, and electronics to deliver high-performance products.

Position Overview

The Senior Process Engineer leads process development, scale-up, and validation for ultrasound transducer manufacturing. Drawing on strong mechanical aptitude and materials knowledge (metals/alloys, ceramics, composites, adhesives), this role drives yield, throughput, and quality by owning process transfer, troubleshooting complex issues, and introducing new technologies.

Key Responsibilities

Own transfer from development to production: define process flows, specifications, inspection criteria; lead pilot builds and IQ/OQ/PQ validations.

Improve and sustain subtractive/precision processes (e.g., dicing saws, CNC micro-machining, thinning/lapping, bonding/curing); set equipment parameters and preventive maintenance.

Lead structured problem solving: perform root cause analysis, implement CAPA, and maintain robust documentation (PFMEA, test methods, drawings, reports).

Apply materials science to optimize acoustic stack processing (backings, matching layers, piezo-ceramics/polymers); investigate and qualify new materials, tooling, and processes.

Use DOE/SPC and data visualization to manage yield, cycle time, and cost; report on process capability and control plans.

Partner with Manufacturing/Operations on capacity planning and scalability; assess and qualify suppliers and external processes.

Coach/mentor junior engineers and technicians; champion compliance to ISO 13485 and support FDA QSR expectations.

Qualifications

Bachelor's or Master's in Mechanical/Manufacturing/Materials Engineering (or related).

~6-10+ years' experience in process/manufacturing engineering, preferably in medical devices or precision manufacturing with high traceability.

Demonstrated success in process scale-up, validation (IQ/OQ/PQ), and production transfer.

Depth in precision/subtractive processes, micro-assembly, adhesive/epoxy handling, and tooling/fixturing.

Proficiency with statistical methods and tools (DOE, SPC; Minitab/JMP).

Experience with piezo-ceramics, advanced polymers, metallization, soldering, or PCBA processes is an asset.

Strong cross-functional leadership, documentation rigor, and communication skills.

Why Join Sonele

Lead the maturation of cutting-edge acoustic manufacturing processes and expand production capability in a growth-stage, quality-driven environment.

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.