Manufacturing Engineer II

Terumo Aortic; Florida; On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Aortic is seeking an engineer to drive process development and tooling across fabrication lines in Florida. You will refine processes, implement cost reductions, and support design transfer from R&D to manufacturing.

The role requires hands-on prototyping, equipment calibration, and data-driven problem solving in a regulated medical device environment. Responsibilities include leading DOE studies, maintaining documentation, and collaborating with manufacturing to ensure quality and

Qualifications

• Bachelor's degree in engineering/science and 3+ years in medical devices.
• Excellent written and verbal communication, strong problem solving.
• Hands-on tooling, prototyping, and design transfer experience.

Responsibilities

• Develop and refine manufacturing processes to boost productivity.
• Lead tool, gauge, and fixture development and calibration.
• Implement cost reductions and DOE-based validations.
• Maintain device history records and process validation protocols.
• Coordinate with engineering and manufacturing to transfer designs.
• Analyze manufacturing data and drive improvement projects.

Skills

Communication

Software

Experimentation

Analytical

Tooling

Prototyping

Project management

Electronics

Polymers/Packaging

Education

Bachelor's degree in engineering/science

Tools

AutoCAD

SolidWorks

Job description

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.

KEY DUTIES

• Work with engineering director 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.

REQUIREMENTS

• Must work within requirements of company handbook and policy statements.
• Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

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 may
• be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• Excellent written and verbal communication skills
• Proficient in software applications
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Hands on abilities to engineer tooling, processes, and equipment.
• Hands on experience building prototypes, tooling, and fixtures.
• If acting as Laser Safety Office (LSO) - Certification of Laser & X-ray safety
• Bachelor's degree in engineering/science and a minimum of 3 years' experience in the medical device industry or equivalent 10+ 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.