conavi
Senior Manufacturing Engineer
Toronto, Ontario · Senior
Sponsorship not specifiedDetected 20 days ago
ExcelERPSolidWorksPower ElectronicsGMPMedical DevicesLeadershipCommunicationCollaborationMicrosoft Office
About the role
- Conavi Medical's Novasight Hybrid System enables simultaneous imaging of a patient's coronary arteries using both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT) technologies.
Responsibilities
- Design, qualify, and implement manufacturing equipment, fixtures, and tooling, focusing on efficiency improvements and ergonomic/safety enhancements
- Lead and execute key projects such as material qualification, tooling and fixture optimization, automation, and line balancing that drive Cost of Goods Sold (COGS) reduction and DFM improvements.
- Develop and monitor critical quality attributes (CQAs) using PFMEA, Control Plans, DOE, SPC, and capability analysis
- Lead root cause investigations, CAPA activities, and process troubleshooting efforts for issues related to product performance, reliability, and integration
Requirements
- Bachelor's or above degree in engineering (Mechanical, Biomedical, Manufacturing, or related field)
- Practical experience in ISO (ideally 13485) and CGMP
- Strong experience with process development, validation (IQ/OQ/PQ), and manufacturing transfer activities
- Proficiency in MS Office (Outlook, Word, Excel, Word, Visio, Access), Minitab, Solidworks, and ERP/MRP systems
- Ability to travel to contract manufacturer and supplier sites across North America as required
- Significant manufacturing engineering experience ideally in the medical device industry.
- Demonstrated skills in the application of root cause analysis, and statistical process control
- Skilled in preparing and updating mfg. documentation such as protocols and reports
- Competencies include teamwork, communication, organizational, attention to detail, and problem resolution
- Conavi Medical values everyone and their contributions.
- We value diversity and encourages applications from all qualified candidates.
- Please let us know if you require accommodations on any of the grounds protected by the Ontario Human Rights Code during the recruitment process.
Skills
- Imagine your future at Conavi!
Benefits
- Contribute to the development, optimization, and scale-up of manufacturing processes for new medical devices in collaboration with internal design teams and external manufacturing partners
- Participate in, and adhere to, health and safety initiatives and requirements
This listing is sourced directly from conavi's careers page and normalized into a canonical job model.