Device and Clinical Package Design Engineer (Hybrid)

Merck•Rahway, NJ

9d•Hybrid

About The Position

As a Device and Clinical Package Design Engineer, you will be part of our R&D team that develops drug delivery systems and designs secondary packaging for combination products in clinical space.

Requirements

Bachelor’s Degree in Mechanical Engineering, Packaging Engineering, or related fields with a minimum of 2 years of design, packaging and mechanical/distribution testing experience.
Proficient in creating solid models, assemblies etc. using computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD, ArtiosCAD etc.
Proficient in creating and reviewing detailed engineering drawings, applying basic GD&T principles for dimensioning and tolerancing.
Knowledge of standards (ASTM/ISTA) for evaluation and qualification of packaging systems.
Ability to perform modeling and structural design of secondary packaging with output for prototyping in multiple materials including paper.
Strong problem-solving, analytical, technical writing and presentation skills with high level of proficiency in utilizing MS Office Suite
Ability to analyze data using statistical software such as Minitab.
Hands on experience in developing test methods and fixtures for tensile tester, conducting method feasibility, Gauge R&R evaluation, and method validation.
Excellent collaborative and communication skills, with a proven ability to work effectively with cross-functional teams and external partners to achieve strategic business goals.

Nice To Haves

Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus.
Experience in the design and development of drug delivery systems such as prefilled syringes and autoinjectors.
Experience in machining, prototyping and 3D printing.

Responsibilities

Demonstrates working knowledge of combination product devices.
Experienced in the design, development, and performance testing of secondary packaging for combination products with demonstrated experience operating packaging CAD programs (Solidworks and Artios) to design machinable, sustainable packaging solutions with deliverable solutions which perform in distribution testing.
Designs, prototypes, conducts testing and analyzes data to inform design development activities.
Has experience in design verification specifically focused on package distribution testing for combination products
Can specify standards for packaging materials not limited to paperboard and corrugate as well as packaging equipment for label application, carton and blister forming.
Can generate drawings and specifications (design outputs) to be captured in Design History File.
Collaborate with systems engineering team to develop robust set of design input requirements based on user needs and target product profile.
Apply DFM/DFA principles to interrogate sourced device and packaging components or design bespoke device or packaging components.
Develop test plans to understand design space and to ensure device and packaging technology is adequately suited for the combination product.
Conduct or analyze tolerance stack ups utilizing worst-case and statistical methods such as RSS or Monte-Carlo simulation.
Identify critical to function/safety and critical to process dimensions and ensure adequate controls exist to maintain device performance within acceptable range.
Interface with key stakeholders in cross-functional development teams and provide technical insight and leadership on the device design aspects of the development program.
Travel to OEMs/Suppliers to review product design, functional data, manufacturing processes and conduct due diligence on robustness of their product and process.
Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.
Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.
Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.
Understand Process validation activities like IQ, OQ, PPQ etc. Review and approve Process validation documentation.