Sr. Engineer, Manufacturing

Terumo•Davie, FL

1d•Onsite

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.comJob SummaryPerforms process, tool, and gauge development and implementation activities, implement cost reductions, develop process layouts, develop, and maintain manufacturing instructions and device history records, and execute process validation protocols, builds and reports

Requirements

Bachelor’s degree in engineering/science and a minimum of (8) eight years’ experience in the medical device industry or (5) five years in the medical device industry with a master’s degree in engineering/science
Project management experience in the medical device industry
Hands-on knowledge of electronics, motion control, plastics, metrology, metallurgy, and manufacturing processes
If acting as Laser Safety Office (LSO) - Certification of Laser & X-ray safety
Experience with polymers, medical grade metals and medical packaging
Ability to organize and conduct experiments independently.
Hands on abilities to engineer tooling, processes, and equipment.
Excellent written and verbal communication skills (English)
Hands on experience building prototypes, tooling, and fixtures.
Ability to analyse and solve technical problems.
Proficient in software applications

Nice To Haves

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
Effective cross-functional communication leadership skills
Preparation and delivery of effective technical presentations to senior management.
Developing organizational "presence" in communications
Provides functional leadership in applying understanding of engineering responsibilities to internal/external customers being supported.
Demonstrated understanding of engineering role and application of engineering skills with developing subject matter expertise
Developing mentor to lower position engineers
Demonstrated innovative thinking and complex problem solving on product and process.
Embraces organizational change and leads improvement opportunities.
Completes individual and leads project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong technical results.

Responsibilities

Work with Manufacturing Engineer Manager and / or Manufacturing Director to determine projects and related tasks.
Manage and lead projects and tasks.
Prepare, analyze, and present data at monthly NCR and Management Review meetings (if applicable)
Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
Manage duties of manufacturing Technician, Intern and Manufacturing Engineers including workload and personal issues (if applicable).
Refine manufacturing processes and flow.
Support & develop new processes that increase productivity and reduce cost.
Implement cost reductions via materials or manufacturing time.
Implement new process and issue process validation protocols and reports.
Develop fixtures, gigs, and gages.
Investigate and provide engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)
Complete investigation, improvements, documentation of preventative and corrective actions (CAPAs)
Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
Document methods for manufacturing and inspection
Work with Research & Development and Process development to develop and transfer new manufacturing process designs to manufacturing.
Log evaluations into Engineering Notebooks
Perform Installation Qualification, Operational qualification, Test method validations, Computer/ software validation and Performance qualification as part of Manufacturing or equipment validation activities.
Perform time studies, process mapping, engineering testing, and DOE.
Utilize statistics to evaluate, justify, and support experiments, analysis, and validations.
Work with Mfg. Supervisor to analyze Manufacturing data, lead improvement projects that come from this analysis and group leader for Projects.
Available to support as a Manufacturing Engineer to support manufacturing Production overtime if it is required.
Develop, document (using AutoCAD / SolidWorks), and implement fixtures, jigs, tools, and gages.
Initiate process, design, and documentation changes through the change management process.
Perform Root Cause Investigations, develop and implement solutions.
Work with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis. (if applicable)
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality
Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times.
Take care of your own health and safety and that of others who may be affected by your actions
Work co-operatively to highlight issues affecting Environmental Health and Safety