Manufacturing Engineer I (TAS)

Terumo•Davie, FL

About The Position

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida. Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart www.terumoaortic.com

Requirements

Bachelor’s degree in engineering or equivalent experience
3+ years of experience in a technical role in the medical device industry
Project management experience in the medical device industry
Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes
Experience with polymers, medical grade metals and medical packaging.
Applies business understanding.
Technical leadership in an area of engineering core competency
Effective application of cross-functional and external resources to engineering activities
Subject matter expertise in QMS and design control requirements in area of engineering focus
Communicates effectively.
Effective cross-functional communication leadership skills.
Preparation and delivery of effective technical presentations to senior management.
Developing organizational "presence" in communications.
Demonstrates customer focus.
Provides functional leadership in applying understanding of engineering responsibilities to internal/external customers being supported.
Develop self and others.
Demonstrated understanding of engineering role and application of engineering skills with developing subject matter expertise.
Developing mentor to lower position engineers.
Drives improvement, innovation, and changes.
Demonstrated innovative thinking and complex problem solving on product and process.
Embraces organizational change and leads improvement opportunities.
Takes accountability for results.
Completes individual and leads project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong technical results.
Teamwork to achieve a common goal.
Demonstrated good leadership and communications skills with ability to collaborate effectively cross-functionally with others.
Ability to form engineering approaches and guide the execution of an engineering team in its execution.

Responsibilities

Supporting the manufacturing engineering team related with updating and implementing SAP/HANA.
Performing process, tool, and gauge development and implementation activities.
Implementing cost reductions.
Developing process layouts.
Developing and maintaining manufacturing instructions and device history records.
Executing process validation protocols, builds and reports.
Working with engineering manager or designee to determine projects and related tasks.
Refining manufacturing processes and flow.
Developing new processes that increase productivity and reduce cost.
Implementing cost reductions via materials or manufacturing time.
Investigating and providing engineering support to Manufacturing processes, SPC, and non-conforming material (NCR).
Preparing, analyzing, and presenting data at monthly NCR and Management Review meetings (if applicable).
Managing Tooling System including preventive maintenance, calibrations, and equipment records (if applicable).
Managing duties of engineer/technician/intern, including workload and personal issues (if applicable).
Completing investigation, improvements, and documentation of preventative and corrective actions (CAPAs).
Utilizing Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
Implementing new processes and issuing process validation protocols and reports.
Developing, documenting (using AutoCAD / SolidWorks), and implementing fixtures, jigs, tools, and gages.
Documenting methods for manufacturing and inspection (Manufacturing Instructions).
Working with Research and Development and Process Development to develop and transfer new designs to manufacturing (lead and manage design transfer projects).
Initiating process, design, and documentation changes through the change management process.
Utilizing statistics to evaluate, justify, and support experiments, analysis, and validations.
Logging engineering evaluations into Engineering Notebooks.
Performing tooling verifications and carrying out IQ/OQ/PQ activities.
Performing Root Cause Investigations, developing and implementing solutions.
Performing process development and executing DOE’s (Design of Experiments).
Working with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis.
Maintaining awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
Working within the QMS always, ensuring accurate completion of records and highlighting issues to immediate supervisor any issues affecting quality.
Ensuring facility, processes and documentation always remain in a state of audit readiness.
Taking care of your own health and safety and that of others who maybe affected by your actions.
Working co-operatively to highlight issues affecting Environmental Health and Safety.