Senior R&D Engineer (sunrise, FL, US) en Terumo Medical Corporation | Home

JOB TITLE

Senior R&D Engineer

DEPARTMENT

Research and Development

JOB CODES

Exempt

MAIN PURPOSE OF JOB AND OBJECTIVES

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 new product development activities, product evaluation and testing, process development, test fixture development and verification/validation protocol and reports.

POSITION IN ORGANISATION

Position in organization can be found on the Organizational Chart via the company intranet.

KEY DUTIES

• Emphasis on functional specialty within the department. This may be associated with innovation, design control, etc. as a subject matter expert.
• Develop, test, and refine prototypes and new product designs.
• Finalize designs and creating detailed engineering specifications ensuring proper tolerancing and design for manufacturability.

• Develop verification/validation protocols, carry out testing and write reports. 
• Lead portions of new product development projects or major design change projects.
• Manage samples’ builds documentation for formal testing programs.
• Assure Design processes are in accordance with design control procedures.
• Develop sub-project timeline for development projects and ensure project execution.
• Develop and implement new processes, test fixtures and documentation methods. 
• Work with Regulatory/ Quality group to carry out functionally specific testing. 
• Work with Physicians/ Marketing to improve existing products and refine prototypes.

• Take part in design reviews and technical product reviews.
• Work with Directors and mangers to carry out project tasks.  
• Evaluate competitor products.
• Investigate field product complaints and develop and implement improvements.
• Supervise technicians and/or lower-level engineers.

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

1. Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorisation of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

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

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may  

be affected by your actions.

2. Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• 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.
• 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.
• Performance based; 3 years or more as an Engineer II
• Bachelor’s degree in engineering/science and a minimum of 5 years’ experience in the medical device industry or master’s degree in engineering/science and a minimum of 4 years’ experience in the medical device industry or technical degree/certificate with appropriately equivalent technical experience in the medical device industry (e.g. 12 years)
• Ability to organize and conduct experiments independently.

• Ability to analyse and solve technical problems.
• Ability to provide design solution to meet design inputs.
• Good oral and written communication skills (English)

• Hands on Experience building prototypes, tooling, test fixtures.
• Working knowledge of plastics, metallurgy, and manufacturing processes

• Use of SolidWorks or similar design tool