172 applicants
Terumo Aortic · 5 days ago
Process Development Engineer
Sunrise, FL
Full-time
Onsite
Mid Level
1+ years exp
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Hiring Manager
Maria Milano
Insider Connection @Terumo Aortic
Responsibilities
Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent grafts.
Develop and implement new manufacturing processes, execute process validations such as IQ, OQ, PQ protocols and reports.
Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
Support the conversion of small-scale processes into commercially viable large-scale operations.
Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
Design tooling and fixtures that will be used for the manufacturing and assembly of products.
Log evaluations into Engineering Notebooks
Create change requests within the company’s change management system.
Other various responsibilities and projects, as necessary
Qualification
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Required
Must work well under pressure.
Knowledge of AutoCAD and SolidWorks or other CAD modelling software.
Knowledge of engineering statistics and data analysis
Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc., is a must.
Able to work closely with a variety of people and teams within the company.
Ability to organize and conduct experiments independently.
Ability to analyse and solve technical problems.
Hands on abilities to engineer tooling, processes, and equipment.
Good oral and written communication skills (English)
Hands on experience building prototypes, tooling, and fixtures.
Sit/Stand/Walk 8 hours per day.
Light lifting
Ability to travel 10-15% of the time.
4 - year engineering degree or equivalent experience, Or a 2 - year technical degree or equivalent experience
1+ years of experience in a technical role in the medical device industry or other manufacturing regulated industry
Working knowledge of equipment design, electro-mechanical, pneumatic components a plus
Working knowledge of Lean Manufacturing and Six Sigma a plus
Working knowledge of materials, injection Moulding and procurement
Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
Project management experience in the medical device industry
Experience with polymers, medical grade metals and medical packaging.
Company
Terumo Aortic
Terumo Aortic is offering services in medical and health sector.
1,001-5,000 employees
Funding
Current Stage
Late StageRecent News
Google Patent
2024-04-15
Google Patent
2024-04-15
Google Patent
2024-04-15
Company data provided by crunchbase
