- 214983 - Sr Engineer – Disposables R&D, Sustaining
- Industry
- ENG
- Region
- MN-Minnesota
- City
- Plymouth
- State
- MN
- Rate
- Up to $40.42 DOE
- Duration
- 12 months
- Description
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
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Robert Davis
rdavis@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x305 or (800) 927-9318 x305
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.