JOB DESCRIPTION:

This section focuses on the main purpose of the job in one to four sentences.
Technical lead for DHF structure within sustaining engineering for disposable medical devices.

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.
• Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
• Manage change controls from initiation through execution.
• Lead the creation and maintenance of design history files.
• Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
• Schedule, budget, and lead engineering project with minimal guidance.
• 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 accommodations may be made to enable individuals with disabilities to perform essential functions.
• Experience in managing medical device product support activities and change controls.
• Experience managing supplier relations & records management.
• Experience managing design output strategies across different product families.
• Experience managing design transfers from R&D to manufacturing.
• Advanced 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.
• Ability to train and coach others from technical expertise.
• Self-directed, resourceful, and able to manage multiple priorities.
• Strong interpersonal, communication, collaboration and influencing skills.
• Ability to read, write and comprehend English.
• Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
• 5 - 8 years of related experience in Class II or Class III disposables medical product development.

• 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.
• Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
• Manage change controls from initiation through execution.
• Lead the creation and maintenance of design history files.
• Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
• Schedule, budget, and lead engineering project with minimal guidance.
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance