Process Engineer

5 days ago

Woodbridge, Ontario, Canada Intellectt Inc Full time

POSITION OBJECTIVE:
The Process Engineer (Product Development) supports process design, development, verification, and validation activities for medical devices. This role ensures compliant and robust process development aligned with ISO 13485, FDA 21CFR 820, and applicable regulatory and customer requirements. The Process Engineer contributes to manufacturability, operational efficiency, and effective design transfer to manufacturing – supporting successful product commercialization and ongoing internal quality system performance.

MAJOR DUTIES:


• Support process development for new products including concept trials, prototyping, DOE, and scale-up activities.


• Develop and optimize manufacturing processes for molding, assembly, bonding, and packaging.
• Participate in DFM/DFA with Design Engineering and clients.


• Define and maintain process requirements, specifications, and acceptance criteria.


• Execute IQ/OQ/PQ validation activities including protocol authorship, execution and reporting.


• Support tooling qualification (T0, T1, FAT/SAT).


• Analyze process capability (Cp/Cpk), yield, and scrap.


• Support root-cause investigations during pilot builds and early production builds.


• Develop PFMEA, Control Plans, and process documentation.


• Collaborate with automation partners, suppliers, and client engineering teams.


• Contribute to continuous improvement to enhance robustness and efficiency.

POSITION REQUIREMENTS:


• Bachelor's degree in Mechanical, Industrial, or related Engineering discipline.


• 1-5 years of process engineering (medical device preferred).


• Strong experience in molding, assembly, and process development.


• Proven experience with validation (IQ/OQ/PQ) and URS/DS/FS packages.


• Skilled in DOE, SPC, and statistical tools (Minitab, JMP)


• Excellent communication skills, able to influence cross-functional discussions with QA/RA, Operations, PMO, Tooling, and suppliers.


• Knowledge of ISO 13485, ISO 9001, and familiarity with risk management principles (ISO and design transfer.


• Ability to write technical design documents and experience preparing Design validation protocols and reports.


• Skilled in developing and maintaining PFMEA and contributing to Risk Management Plans and ISO 14971 documentation.

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