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Manufacturing Engineer
4 weeks ago
Imagine your future at Conavi
Join our collaborative and entrepreneurial team in designing, manufacturing, and selling minimally invasive imaging solutions to improve cardiac care around the world.
Conavi Medical's Novasight Hybrid System enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT).
If you would like to be a part of our growing and talented team that is making a difference in healthcare, we are currently looking for a Manufacturing Engineer to develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications, quality standards and the business objectives.
In this position, you will:
- Support a low-volume and high complexity production line by troubleshooting issues and non-conformances, performing root cause analysis, and driving resolutions
- Evaluate existing and develop new manufacturing processes by analyzing production data and gathering information from colleagues in production and quality control, and development engineering; guide others in the development of their designs and approve the designs as required
- Design, document and provision the manufacturing processes for the improvement of existing processes, design of new technologies, and/or scaling up of production volumes
- Collaborate with sustaining engineers and production technicians to implement design for manufacturing
- Design/fabricate or select tooling, automation, test equipment for production
- Develop and implement the control and calibration procedures for tooling, automation and test equipment; guide others in the development of their proposals or plans; review and approve the proposals of others as required
- Develop and monitor process control points in mfg. process and testing requirements/procedures; develop and maintain statistical controls; guide others in the development of their process control points and testing requirements/procedures; review and approve the proposals of others as required; analyse the team's collective statistical control reports, identify issues and develop proposed solutions
- Develop and deliver clear training materials for production staff
- Listen to production staff and support the resolution of challenges or the introduction of process improvements
- Collaborate with suppliers of outsourced parts, assemblies and products to resolve quality or supply issues
- Participate in the investigation and resolution of Corrective Action and Preventative Action (CAPA)
- Validate and verify production processes including preparing and presenting validation and verification reports; review team's validation and control reports to improve report quality and identify larger issues for review with leadership
- Develop and implement initiatives that drive efficiency and increase product yields
- Participate in, and adhere to, health and safety initiatives and requirements
You possess the following qualifications:
- Bachelor's or above degree in engineering (mechanical, electrical, industrial, or similar)
- Manufacturing/process engineering experience in low to medium volume and high complexity manual assembly line environments as well as scaling up production and transferring a product under development to manufacturing preferably within the medical device industry
- Experience with the knowledge areas relating to manufacturing such as work instructions, Device History Records, supply chain and inventory management, and Lean Six Sigma
- Working knowledge of ISO (ideally 13485) and CGMP
- Proficiency in MS Office (Outlook, Word, Excel, Word, Visio, Access) and ERP or MRP systems
- Competencies including teamwork, communication, coaching, organizational, problem solving, and self-initiative
Conavi Medical values diversity and encourages applications from all qualified candidates including women, visible minorities, indigenous people, and persons with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Please submit a cover letter and 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.
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