Job Details

Target PR Range: 38-43/hr DOE

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, defend inspection and ensure the follow through of commitments.

Essential skills and 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

Preferred Qualifications:
* Bachelors Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
* Minimum 2 year of scientific or engineering experience in a GMP regulated environment
* Statistical Analysis software (Minitab or JMP)
* Strong technical writing skills
* CAD fixturing software (SolidWorks)
* Tolerance Stack-Ups (2D, 3D, RSS)
* 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