Engineer, Medical Devices; JP

Position: Engineer, Medical Devices (JP12013)
Job Title:Engineer, Medical Devices (JP12013)
Location:Thousand Oaks, CA. 91320
Business Unit:PFS And Lyo Kit Platforms
Employment Type: Contract
Duration:1+ years with possible extensions or conversion to FTE
Rate
: $37 - $41/hour W2
Posting Date:11/27/2023
Notes:ONSITE - no remote, heavy lab role. considering candidates in a reasonable radius from the thousand oaks site.

3 Key Consulting is recruiting an
Engineer
for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate
:
Excellent communication,
forced testing software experience, design verification testing, proficiency with MS suite. Bachelors relevant engineering or any scientific field as long as they have hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab). Willing to consider those with relevant internship experience.

Job Description:
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, and defend inspection and ensure the follow through of commitments.

Basic Qualifications:
Master degree
OR Bachelor degree and 2 years of experience
OR Associate degree and 6 years of experience

Top Must Have Skill Sets:

• Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
• Good Communication and Technical Writing Skills
• Ability to Multitask

Day to Day Responsibilities:

• The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
• The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems.
• The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material.
• Fill-Finish experience is a bonus but not mandatory.
• Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Employee Value Proposition: great opportunity for growth in career

Why is the Position Open?
Supplement additional workload on team.

Red Flags:

• No previous industry or laboratory experience
• Unfamiliar with Good Documentation Practices
• Poor communication
• No technical writing.

Interview Process:
Individual Interviews (x2) - Webex or In-person
Panel Interview (x1) – Webex

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our  You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role.
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