Manufacturing Process Engineer

The Manufacturing Process Engineer supports the development, implementation, and optimization of manufacturing processes in a highly regulated environment. This role works closely with Manufacturing, Quality, Regulatory, and Operations teams to ensure that processes are safe, compliant, efficient, and production-ready, contributing directly to the advancement of nuclear medicine and the improvement of patient outcomes.

• Develop, implement, and continuously improve manufacturing processes and production workflows to enhance safety, quality, and efficiency.
• Collaborate closely with Manufacturing, Quality, Regulatory, and Operations teams to define process and equipment requirements that meet technical and regulatory standards.
• Lead process development initiatives, including process validation and continuous improvement projects, to support reliable and scalable production.
• Create, update, and maintain engineering documentation such as drawings, bills of materials (BOMs), process specifications, and detailed work instructions.
• Perform Process Failure Mode and Effects Analysis (PFMEA) and support risk assessments to identify, evaluate, and mitigate manufacturing risks.
• Troubleshoot manufacturing issues related to tooling, fixtures, equipment, and mechanical processes, implementing corrective and preventive actions.
• Support equipment installation, commissioning, qualification, and optimization to ensure robust and compliant operation.
• Ensure compliance with quality systems, regulatory requirements, Good Manufacturing Practice (GMP) standards, and engineering safety principles.
• Participate in root cause investigations and lead or support corrective actions and process improvement efforts to prevent recurrence of issues.
• Partner with quality and regulatory teams to maintain documentation and processes that meet audit, inspection, and regulatory expectations.
• Contribute engineering expertise to cross-functional project teams focused on advancing nuclear medicine technologies and healthcare solutions.

• At least 5 years of mechanical manufacturing or process engineering experience in a production environment.
• Proven experience working in a highly regulated environment, with a strong preference for medical or pharmaceutical manufacturing.
• Hands-on experience with process validation, including planning, execution, documentation, and analysis of validation activities.
• Demonstrated ability to troubleshoot manufacturing processes, equipment, tooling, and fixtures, and implement effective solutions.
• Experience leading or participating in continuous improvement initiatives using methodologies such as Lean and Six Sigma.
• Practical experience conducting PFMEA and formal risk assessments for manufacturing processes and equipment.
• Strong understanding of quality systems, GMP requirements, and regulatory compliance in a manufacturing setting.
• Knowledge of engineering safety principles and their application in process and equipment design and operation.
• Experience creating and maintaining manufacturing documentation, including work instructions, drawings, process specifications, and BOMs.
• Ability to collaborate effectively with cross-functional teams including Manufacturing, Quality, Regulatory, and Operations.

• Experience in pharmaceutical or medical device manufacturing environments.
• Familiarity with nuclear medicine or other specialized healthcare manufacturing fields.
• Exposure to Lean Six Sigma tools and methodologies to drive process efficiency and waste reduction.
• Strong documentation skills with attention to detail and accuracy in technical records.
• Ability to contribute to long-term, multi-year projects and adapt to evolving technical and regulatory requirements.
• Interest in advancing healthcare and contributing to meaningful innovation in a growing and highly specialized industry.

This is a Contract position based out of Ottawa, ON.

The pay range for this position is $50.00 - $65.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

This is a Contract position based out of Ottawa, ON.

This is a fully onsite position in Ottawa,ON.

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