Sr. Engineer Disposables R&D, Sustaining
Sr. Engineer Disposables R&D, Sustaining
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- This section contains a list of primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Lead and support small to medium sized projects with global crossfunctional teams in the implementation of design changes (e.g. new features suppliers materials labeling CAPA/Client cost reduction remediation).
- Identify investigate and solve engineering problems utilizing riskbased and customer focused approaches and engineering tools. (e.g. dFMEA Human Factors Engineering statistical software CAD).
- Create modify and maintain design history file documentation including protocols reports design specifications labeling and design drawings.
- Develop and execute test method validations product testing and verification / validation activities.
- Build prototypes and models. May operate machine tools design and build basic tooling test fixtures and assembly equipment.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
Requirements:
- To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
- List knowledge skills and/or abilities required.
- Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
- Working knowledge of plastics materials and processing such as injection molding extrusion ultrasonic welding UV/solvent bonding and sterilization.
- Working knowledge of CAD and PDM enterprise software (e.g. Creo SolidWorks).
- Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices Application of Risk Management to Medical Devices.
- Takes initiative with a high aptitude for learning innovation and implementing best practices and continuous improvements.
- Strong collaboration verbal and written communication skills.
- Strong attention to detail organized and able to independently manage multiple priorities.
- Ability to read write and comprehend English.
- Experience and/or Background BS in Mechanical Plastics Biomedical Engineering or a related field MS preferred.
- 3 5 years of related experience in Class II or Class III disposables medical product development.
- Design for Six Sigma (DFSS) training or certification preferred.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
