Sr. Engineer, Manufacturing

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

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

Job Details/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)

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 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.

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

Knowledge, Skills and Abilities (KSA)

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.

Qualifications/ Background Experiences

• 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

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.