Engineer, Drug Product – Prefilled Syringes (JP13400)

3 Key Consulting•Thousand Oaks, CA

2d•Onsite

About The Position

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, defend inspection and ensure the follow through of commitments.

Requirements

Hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork.
Experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable.
Proficiency in Microsoft Office is required.
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Lack of hands-on experience in engineering or a translatable field like farming or factory work.
Poor communication or teamwork skills, especially for candidates with no collaborative experience.
Unwillingness to relocate or commute daily to ATO for this on-site role.
Weak technical writing skills.
Reliance solely on theoretical or textbook knowledge without practical application.
No experience in relevant industries, such as medical device manufacturing, biopharma, or packaging.

Nice To Haves

CAD/SolidWorks skills are a plus.
Entry-level candidates with practical experience, such as internships, are preferred, while overqualification (e.g., PhD or advanced degrees with extensive experience) is less desirable.
Packaging engineering knowledge is a bonus but not mandatory.
Statistical Analysis software (Minitab or JMP)
CAD fixturing software (SolidWorks)
Instron force tester using BlueHill Universal
Experience with design controls; including (but not limited to) verification and design transfer
Understanding of risk assessments including hazard and probability analysis
Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Ability to work independently and dynamically across functional teams
Excellent written and verbal communication skills
Ability to support complex workstreams under demanding timelines
Fill-Finish experience is a bonus but not mandatory.

Responsibilities

Adheres to strict documentation practices in a GMP regulated environment
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
Authors and reviews technical documentation including protocols, reports, and technical assessments
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Maintains combination product design history files for assigned products
Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
At a minimum familiar with the following standards and regulations: Quality System Regulation – 21CFR820 Risk Management – ISO 14971 EU Medical Device requirements – Council Directive 93/42/EEC
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.
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.