Process Engineer III

Baylis Medical Technologies•Mississauga, ON

30d•CA$73,000 - CA$90,000•Hybrid

About The Position

The successful candidate will lead the design, development, and implementation of manufacturing processes and technologies, supporting DMS and Radiology products. As a member of a cross-functional project core team, they will ensure that process development and validation activities are completed in accordance with the Baylis Quality Management System and enable successful transfer of products into production. In this role, the candidate will execute advanced process engineering work within established procedures, contribute to project planning, and develop independent work plans to meet project objectives. They will also initiate and support continuous improvement efforts to enhance process efficiency, quality, and overall performance.

Requirements

Bachelor's degree in Engineering
3–7 years of relevant engineering experience in the medical device industry
Experience in process design/development, design for manufacturability, and product/process validation (IQ/OQ/PQ)
Strong experience with structured problem solving, root cause analysis, and process optimization techniques (e.g., SPC)
Knowledge of risk management principles (ISO 14971) and experience applying them in engineering decisions
Experience supporting or contributing to project planning and managing independent work plans
Familiarity with tooling/fixture design and manufacturing process development
Strong analytical, organizational, and communication skills (written and verbal)
Proficiency in MS Office
Professional Engineer (P.Eng.) license in Ontario is required, or candidates must be actively eligible and pursuing licensure. Candidates who do not hold a P.Eng. at the time of hire will perform engineering work under the supervision of a licensed Professional Engineer in accordance with the Professional Engineers Act (Ontario), and their title will be aligned accordingly until licensure is obtained.

Nice To Haves

Lean or Six Sigma certification or training
Experience with catheter manufacturing or similar high-precision medical device processes

Responsibilities

Lead the design, development, and implementation of manufacturing processes and technologies for DMS and Radiology products
Execute advanced process engineering work using defined procedures, applying structured problem solving, root cause analysis, and statistical methods (SPC) to improve yield and process capability
Plan, implement, and coordinate new product introductions, including product design, specifications, process validation (IQ/OQ/PQ), equipment and layout, and production readiness
Collaborate with cross-functional SMEs to develop, validate, and transfer processes to production in accordance with the Baylis Quality Management System
Develop and manage independent work plans, contributing to project planning and prioritizing activities to meet timelines and objectives
Design and implement tooling, fixtures, and manufacturing processes to enhance capability, efficiency, and scalability
Lead continuous improvement initiatives by identifying trends, driving corrective actions, and optimizing overall process performance
Maintain accurate, traceable documentation and support change control activities (ECO/ECN) and audit readiness
Provide technical guidance to technicians, engineering assistants, and junior engineers, supporting effective execution of project deliverables
Adhere to all Quality Management System (QMS), regulatory (GMP, ISO), and company requirements
Demonstrate Baylis values, work with integrity, and contribute as a collaborative team member
Comply with Health & Safety policies and escalate unsafe conditions as required