Job Description
Role Summary
The 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 in Mechanical/Manufacturing/Materials Engineering (or related).
- 3+ 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.
Salary Range
CAD$65,000 – $80,000 annually.
Why Join Sonele
At Sonele, you'll be part of a multidisciplinary team driving complex medical devices from idea to production. You'll lead programs that combine precision engineering with real-world healthcare impact—supported by an organization committed to innovation, quality, and long-term customer partnerships.
This is an opportunity to shape technical outcomes, interface directly with innovators, and help grow Canada's hub for advanced medical device development.
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.
Please note that artificial intelligence (AI) technologies may be used during this recruitment process to assist with the evaluation of applications. These tools support, rather than replace, human judgment.