Job Description
JOB TITLE
Associate Customs Engineer
DEPARTMENT
Global Custom Solutions
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.
Perform new product development activities, product evaluation, and testing, process development, test fixture development, verification/validation protocol and reports.
KEY DUTIES
- Work with project leaders to carry out project tasks.
- Develop, test, and refine prototypes and new product concepts.
- Develop verification/validation protocols, carry out testing, data analysis and write reports.
- Evaluate competitor products.
- Develop new processes and test fixtures and document methods.
- Work directly with Physicians/ Marketing to improve products and refine prototypes.
- Investigate field product complaints.
- Understanding of GMP/ISO requirements
- Ability to organize, set up and conduct experiments independently.
- Ability to analyze and solve technical problems.
- Protocol writing and report writing.
- Written communication/Reports
- Competent computer skills i.e. Microsoft Word, Excel, AutoCAD, etc.
DIMENSIONS & LIMITS OF AUTHORITY
COMPANY
REQUIREMENTS
- 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
- 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
- Ability to interact with all levels within the organization.
- Analytical skills for compiling and analyzing data.
- Computer and software skills
- Ability to motivate others and improve efficiency.
- Sit/Stand/Walk 8 hours per day.
- Light Lifting
- 4 – year engineering/science degree
- Technical degree/Certificate with equivalent experience (5 years technical experience in the medical device industry)
- 4-year degree: No previous experience needed
- 2-year degree: Minimum of 5 years technical experience in the medical device industry
- Strong written, verbal, analytical, and interpersonal skills.Self-motivated. Ability to multitask. Time management and organizational skills.
- Ability to travel as required up to 20% of the time.
- Normal office/lab environment.