If you would like to be a part of a talented team that is making a difference in healthcare, we currently have a new opening for a Senior Manufacturing Engineer to develop, validate, and optimize the manufacturing processes for Conavi's medical device including the catheter-based products and durable electromechanical assemblies at our manufacturing partners ensuring that all devices are built to the highest standards of quality, cost, efficiency, and scalability.
In this position, you will:
- 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
- Support design transfer, pilot builds, manufacturing readiness, and commercialization activities in both disposable catheter and durable electromechanical systems including mechanical assemblies, PCBA, cable harnesses, sensors, motors, and power subsystems.
- Develop and execute IQ/OQ/PQ validations for catheter-based disposable products (e.g. bonding, coating, assembly, packaging, and testing) and durable electromechanical assemblies (e.g. consoles, power systems, imaging modules, and mechanical sub-assemblies).
- 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
- Coach and mentor other manufacturing engineers and provide technical leadership across cross-functional teams
- Participate in, and adhere to, health and safety initiatives and requirements
You possess the following qualifications:
- Bachelor's or above degree in engineering (Mechanical, Biomedical, Manufacturing, or related field)
- Significant manufacturing engineering experience ideally in the medical device industry.
- Practical experience in ISO (ideally 13485) and CGMP
- Demonstrated skills in the application of root cause analysis, and statistical process control
- Strong experience with process development, validation (IQ/OQ/PQ), and manufacturing transfer activities
- Skilled in preparing and updating mfg. documentation such as protocols and reports
- Proficiency in MS Office (Outlook, Word, Excel, Word, Visio, Access), Minitab, Solidworks, and ERP/MRP systems
- Competencies include teamwork, communication, organizational, attention to detail, and problem resolution
- Ability to travel to contract manufacturer and supplier sites across North America as required
Please submit a resume directly to Conavi Medical through the Careers section of our website at www.conavi.com. We thank all candidates for their interest but only those selected for an interview will be contacted.
