Mechanical Design and Manufacturing Engineer

Department: Manufacturing

Site: 3505 Laird Road Mississauga Ontario. Moderate travel (10% 30%) is expected.

Reports to: Manufacturing Engineering and Service Manager

Hours: 37.5 hours per week

Status: Permanent Full-time

Duties and Responsibilities:

Engineering and Manufacturing Support:

• Collaborate with cross-functional teams including R&D Quality Assurance and Production to ensure successful manufacturing operations.
• Participate in the design and optimization of manufacturing processes workflows and assembly methods to improve efficiency reduce costs and enhance product quality.
• Design and develop manufacturing jigs fixtures and tooling to aid in the assembly and testing of medical devices.
• Monitor production lines identify potential bottlenecks or issues and implement corrective actions as needed.
• Assist in the creation and maintenance of manufacturing work instructions standard operating procedures (SOPs) and documentation.

New Product Introduction (NPI):

• Contribute to the NPI process by providing engineering expertise in the evaluation of new designs prototypes and components.
• Collaborate with R&D and design teams to ensure seamless transfer of products from development to production.
• Support the validation and verification activities for new products ensuring they meet regulatory requirements and quality standards.
• Write IQ/OQ/PQ and execute new equipment validation and verification.
• Creating manufacturing process maps and process failure mode and affect analysis (PFMEA).
• Participate in risk assessment and mitigation strategies during the NPI phase.

Client Equipment Field Servicing:

• Act as a technical resource for clients by providing on-site servicing and maintenance of medical equipment ensuring optimal performance and adherence to manufacturer specifications.
• Troubleshoot and diagnose technical issues related to medical devices utilizing problem-solving skills and technical knowledge to resolve issues promptly.
• Conduct routine preventive maintenance and calibration of medical equipment at client locations.
• Train clients on proper usage maintenance and troubleshooting of equipment to ensure safe and effective operation.

Continuous Improvement:

• Identify opportunities for process improvement quality enhancement and cost reduction within manufacturing and servicing activities.
• Actively participate in root cause analysis and corrective action implementation for any identified issues.

Documentation and Compliance:

• Maintain accurate and up-to-date records of all manufacturing NPI and servicing activities ensuring compliance with regulatory requirements.
• Contribute to the preparation of technical reports performance summaries and documentation for regulatory submissions.

Qualifications :

• Bachelors degree in engineering (Mechanical Biomedical or related field).
• 3-5 years of experience in manufacturing engineering and field servicing ideally in medical devices.
• Strong understanding of manufacturing processes quality standards and NPI principles.
• Familiarity with medical device regulations (FDA ISO 13485) and quality management systems.
• Excellent problem-solving skills and ability to troubleshoot technical issues.
• Effective communication and interpersonal skills for cross-functional collaboration and client interactions.
• Willingness to travel to client sites for equipment servicing (estimated 10-30% travel).
• Knowledge of SolidWorks (and PDM) CAD software.
• Knowledge in creating manufacturing process maps and process failure mode and affect analysis (PFMEA).
• Basic programming skills for equipment calibration and diagnostics.

Remote Work :

No

Employment Type :

Full-time