- 214982 - Principal Engineer – Disposables R&D, Sustaining
- Industry
- ENG
- Region
- MN-Minnesota
- City
- Plymouth
- State
- MN
- Rate
- Up to $58.59 DOE
- Duration
- 12 months
- Description
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.
PREFERRED QUALIFICATIONS (DESIRED SKILLS/EXPERIENCE):
Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
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
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Patricia Serge
pserge@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x306 or (800) 927-9318 x306
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.