R&D Design Engineer II

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 8 days ago

Vacancies: 1 Vacancy

Job Summary

MUST HAVE MEDICAL DEVICE INDUSTRY EXP.

Job Description:

Position Title: R&D Design Engineer II
Location: Onsite/Hybrid Role in Irvine CA 92612
Contract Period: 12 Months
Shift Timings: Mon - Fri 08:00 AM - 05:00 PM PST

Location: Irvine CA - Hybrid Required (M/F Remote - T/W/TH Onsite)
Contract: 1 year - based on performance and business needs

Client is looking for a Development Engineer in the Irvine Engineering Testing & Analysis group (ETAG) within Device & Combination Product Development (DCPD).
This is a key role with a direct impact on Clients exciting and rapidly growing portfolio of combination products with a major focus on Eye Care and Neurotoxins products.
This role will lead project activities and work on his/her own projects while contributing engineering insights into multiple other projects.

What are the top 3-5 skills experience or education required for this position:

Experience creating engineering drawings proficiency with GD&T dimensioning CAD design (Solidworks) and tolerance stack analysis
Experience with ISO 13485 and 14971 quality system and risk management principles
Experience with design control DHF documentation and good manufacturing/documentation practices
Experience with fixture design fixture development test method validation
Experience with statistical software (minitab or JMP) Six Sigma statistics and Design of Experiments

Responsibilities:

Demonstrate creative out of the box thinking to solve difficult problems and develop new technologies to achieve project goals.
Design and execute design of experiments and fixture development to support feasibility development and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
Define develop and validate/transfer test methods.
Create verification plans protocols records and reports. Support investigations and issue resolutions.

Qualifications

A degree in an engineering field (mechanical materials packaging bioengineering): BS or equivalent education with 4 years of experience; MS or equivalent education with 3 years of experience
Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
Significant background in engineering testing and analysis including:
Direct experience of test equipment validation (IQ OQ PQ) is required.
Must be able to demonstrate relevant experience in statistical analysis.
Documentation experience including standard operating procedures (SOPs) technical reports and design verification plans/protocols/reports.
Proficiency in MS Office MS Project Solidworks Minitab or JMP.
Lean Six Sigma 5S experience desired.
Good communication skills both written and oral. Ability to prepare technical reports and presentations.

MUST HAVE MEDICAL DEVICE INDUSTRY EXP. Job Description: Position Title: R&D Design Engineer II Location: Onsite/Hybrid Role in Irvine CA 92612 Contract Period: 12 Months Shift Timings: Mon - Fri 08:00 AM - 05:00 PM PST Location: Irvine CA - Hybrid Required (M/F Remote - T/W/TH Onsite) Contract: 1...