Chipton Ross is seeking a Sr. Engineer - Disposables R&D, Sustaining for a contract opportunity in Plymouth, MN.
BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
o Experience working with external manufacturing partners and supplier relations.
o Experience creating and modifying medical device design outputs including receiving and inspection criteria.
o Experience in medical device product support and change control management.
o Experience in design transfer from R&D to manufacturing.
o Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
o Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
o Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
o Strong collaboration, verbal and written communication skills.
o Strong attention to detail, organized, and able to independently manage multiple priorities.
o Ability to read, write and comprehend English.
POSITION RESPONSIBILITIES:
o Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.
o Create, modify, and maintain design history files.
o Perform change control assessments.
o Work closely with project manager and technical lead to achieve project commitments.
o Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
PREFERRED QUALIFICATIONS (DESIRED SKILLS/EXPERIENCE):
Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
o 3 - 5 years of related experience in Class II or Class III disposables medical product development.
o Design for Six Sigma (DFSS) training or certification preferred.
REQUIRED EDUCATION:
Relevant Bachelor's degree required
WORK HOURS:
First Shift, Full Time
Chipton-Ross