- 214323 - 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.
BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
o Advanced knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
o Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
o Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).
o Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
o Creative Problem Solver - identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
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 Schedule, budget, and lead engineering projects with minimal guidance.
o Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
o Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
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 Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
o May supervise engineers and/or technicians.
o May contribute to client intellectual property through invention disclosures and patent applications.
PREFERRED QUALIFICATIONS (DESIRED SKILLS/EXPERIENCE):
o 5 - 8 years of related experience in Class II or Class III disposables medical product development.
REQUIRED EDUCATION:
Accredited BS Degree in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
WORK HOURS:
Monday-Friday
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Kevin Suk
ksuk@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x230 or (800) 927-9318 x230
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.