Principal Engineer - Disposables R&D, Sustaining REMOTE - ZipRecruiter : Job Details
Principal Engineer - Disposables R&D, Sustaining REMOTE
ZipRecruiterJob Location : Myrtle Point,OR, USA
Job DescriptionJob Description
Hiring NOW
18-month contract in Plymouth, MN
Job will run through 12/2026
Chipton Ross is seeking a Principal Engineer - Disposables R&D, Sustaining for a contract opportunity in Plymouth, MN.
JOB SUMMARY
Technical lead for DHF structure within sustaining engineering for disposable medical devices.
BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
o Experience in managing medical device product support activities and change controls.
o Experience managing supplier relations & records management.
o Experience managing design output strategies across different product families.
o Experience managing design transfers from R&D to manufacturing.
o Advanced 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 Ability to train and coach others from technical expertise.
o Self-directed, resourceful, and able to manage multiple priorities.
o Strong interpersonal, communication, collaboration and influencing skills.
o Ability to read, write and comprehend English.
POSITION RESPONSIBILITIES:
o Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
o Manage change controls from initiation through execution.
o Lead the creation and maintenance of design history files.
o Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
o Schedule, budget, and lead engineering project with minimal guidance.
o Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
QUALIFICATIONS (DESIRED SKILLS/EXPERIENCE):
Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS .
o 5 - 8 years of related experience in Class II or Class III disposables medical product development.
REQUIRED EDUCATION:
Relevant Bachelor's degree required
WORK HOURS:
First Shift, Full Time
Hourly pay rate is: $ 58.59