Validation & Verification Engineer, Medical Drug Delivery Device (Hybrid) - (JP10785)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Validation & Verification Engineer, Medical Drug
Delivery Device (Hybrid) - (JP10785) Location: Thousand Oaks, CA
(Hybrid, once a week or once bi-weekly on site) Employment Type:
Contract to Hire Business Unit: AutoTouch Drug Delivery Device -
Platform Team Duration: 1 years with likely extensions or
conversion to permanent Posting Date: 09/07/2022. Note: Consultant
needs to be on site 2 - 4 times per month. 3 Key Consulting is
hiring a Validation Engineer for a consulting engagement with our
direct client, a leading global biopharmaceutical company. Job
Description: Scope includes electro-mechanical delivery devices,
such as fluid transfer devices, reusable automatic injectors, or
micro-infuser delivery pump systems with the embedded firmware and
hardware. The qualified candidate will be part of a sustaining
device engineering team that ensures the design history files of
these systems are maintained. The engineer will participate in
multi-functional teams, device verification activities such as
revising product requirement specifications, supporting new
development project teams, analytical failure analysis and
implementing design solutions, authoring verification protocols and
compiling verification report and getting them ready for approval.
Responsibilities : Accountable for maintaining technical records
within design history files associated with assigned products.
Support system-level design, development, and V&V work for
commercial lifecycle management changes or in support of new
project development. Develop test methods, generate, and maintain
design specifications, protocol & report writing, prototyping,
DOE/SPC product optimization, design verification & validation,
FMEA, etc. Participate system-level and subsystem-level root cause
investigation from firmware and electrical perspective, coordinate
design improvements with development partners, tactical planning,
and execution of design changes and improvements.\ Supports Product
Delivery Teams (PDT), including creating and or reviewing quality
documents, participating in Corrective And Preventive Action (CAPA)
implementation, and generating or supporting ECR (Engineering
Change Request) & ECO (Engineering Change Order) activities. Works
with Scientists and Engineers internally and externally to assess
and develop appropriate design and manufacturing specifications.
Basic Qualifications: Doctorate Degree, or Master’s Degree and 2
years of Engineering and/or Operations experience within a cGMP
manufacturing environment/ OR within a biotech or medical device
manufacturing environment, or Bachelor’s Degree and 4 years of
Engineering and/or Operations experience within a cGMP
manufacturing environment/ OR within a biotech or medical device
manufacturing environment. Preferred Qualifications: Master’s
degree in biomedical/electrical/computer science or related
Engineering field and 4 years of related engineering experience A
background in the development and commercialization of class II or
class III electromechanical medical devices especially drug
delivery devices, syringe and vial fill process Systems Engineering
design experience and thinking, driving user needs to design
requirements to verified and validated final product outputs
through design requirement management system such as DOORs,
RequisitePro, Quality Center or equivalent. Strong understanding
and experience in design controls, life cycle management through
design change control process, failure investigation and root cause
analysis, initiating and bringing complex projects to conclusion
Familiar with the following standards and regulations: Quality
System Regulation – 21CFR820, Risk Management – ISO 14971, EU
Medical Device requirements – Council Directive 93/42/EEC, Drug
delivery device and needle standard - ISO 11608-1/ISO 11608-4/ISO
11608-5/ISO_23908, and biocompatibility standard - ISO 10993
Familiar with electrical schematic design and layout, and embedded
software coding structure and workflow Understanding of Medical
Device software and hardware design requirements. Understanding of
ISO 62304 and FDA software validation requirements Ability to work
independently and across functional teams. Excellent (technical)
written and verbal communication Top Must-Have Skill Sets: Willing
to look at new grads- ideal candidate 2 years BS or MS degree in
engineering, biochemistry, biomedical, chemistry Knowledge or
experience of IEC60601, ISO13485, ISO 14791 or FDA Title 21 CFR 820
(preferred) Software and/or hardware background Red Flags: No BS
degree No engineering or science background, nonrelated experience
Interview process: Phone screen, then panel video interview. We
invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to take a
look at the other positions on our website
www.3keyconsulting.com/careers. You are welcome to also share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Redondo Beach , Validation & Verification Engineer, Medical Drug Delivery Device (Hybrid) - (JP10785), Engineering , Thousand Oaks, California
