Manufacturing Engineer I

Terumo Aortic; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Terumo Aortic is seeking a Manufacturing/Process Engineer to support the manufacturing engineering team with SAP/HANA updates, process development, and cost-reduction initiatives. You will develop fixtures, jigs, tools, and gauges using AutoCAD or SolidWorks, while maintaining device history records and execution of validation protocols.

The role requires hands-on knowledge across electronics, plastics, metals and polymer packaging, plus experience in DOE, NCRs and CAPAs to drive continuous

Qualifications

• 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.

Responsibilities

• Support the manufacturing engineering team with updating and implementing SAP/HANA.
• Develop and implement process layouts, tooling, gauges, and manufacturing instructions.
• Lead process improvements to increase productivity and reduce cost.
• Document and validate processes through IQ/OQ/PQ activities and CAPAs.
• Manage tools and equipment records and calibration.
• Assist in design transfer and development from R&D to manufacturing.

Skills

Technical leadership

Cross-functional collaboration

QMS & design control

Engineering problem solving

DOE (Design of Experiments)

Education

3+ years in medical device engineering

Tools

AutoCAD

SolidWorks

Job description

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

Job Summary

Responsible for supporting the manufacturing engineering team related with updating and implementing SAP/HANA. Performs 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.

• Work with engineering manager or designee to determine projects and related tasks.
• Refine manufacturing processes and flow.
• Develop new processes that increase productivity and reduce cost.
• Implement cost reductions via materials or manufacturing time.
• Investigate and provide engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)
• 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 engineer/technician/intern, including workload and personal issues (if applicable)
• Complete investigation, improvements, and documentation of preventative and corrective actions (CAPAs)
• Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
• Implement new processes. and issue process validation protocols and reports
• Develop, document (using AutoCAD / SolidWorks), and implement fixtures, jigs, tools, and gages.
• Document methods for manufacturing and inspection (Manufacturing Instructions)
• Work with Research and Development and Process Development to develop and transfer new designs to manufacturing (lead and manage design transfer projects)
• Initiate process, design, and documentation changes through the change management process
• Utilize statistics to evaluate, justify, and support experiments, analysis, and validations.
• Log engineering evaluations into Engineering Notebooks
• Perform tooling verifications and carry out IQ/OQ/PQ activities.
• Perform Root Cause Investigations, develop and implement solutions.
• Perform process development and execute DOE’s (Design of Experiments)
• Work with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

QUALITY REQUIREMENTS

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who maybe affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• 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.
• 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.

Qualifications/ Background Experiences

• 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.