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R&D Design Engineer II

Irvine, CA, US • Posted 2 days ago • Updated 1 hour ago

Contract W2

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Design Control
CAD Design
ISO 13485 and 14971
GD&T dimensioning
DHF documentation

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 Client's 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91090330
Position Id: 2026-3679
Posted 2 days ago

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