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Job Description

Position Title: Senior Engineer, Combination Products (Branchburg, NJ)

Reporting Structure: As per current organizational chart

Position Summary: As part of the BD/ZebraSci Combination Product Services team, the Senior Engineer, Combination Products, will assist with technical and scientific activities related to combination product test method development and execution and will serve as a technical contact for pharmaceutical customers and ZebraSci laboratory operations.

This position performs technical analyses of drug delivery systems, designs fixturing, develops and validates test methods, and helps implement new testing technologies. S/he will plan, perform and analyze bench-level engineering tests or research experiments for drug-device combination products and medical devices. Position requires that candidate may perform tests to support operations.

Essential Duties and Responsibilities

• Uses technical expertise to contribute to the customer sales process, service delivery, and maintains a customer-focused outlook:

• Supports the Combination Product Services team to accurately collect, analyze, challenge, and synthesize customer requests/inputs and translates these into appropriate responses, solutions, services, and action plans

• Educates on technical aspects of combination products and testing services as appropriate:

• Advises on service and/or product solutions for needs

• Answers technical questions

• Aids in the scoping of testing approaches, fixturing, protocols, and method validation and in the timely delivery of projects to customers

• Closely coordinates with internal cross-functional team (business development, quality, service operations) to discuss and resolve challenges with service projects, and provide updates

• Develops training modules, videos, or other materials as appropriate on ZebraSci products, services, and/or processes

• Develops, maintains, and diffuses combination product services technology:

• Supports technical initiatives related to combination products testing services, methodologies, and instrumentation.

• Stays abreast of changing regulations, standards and environment relevant to combination products and impacting the component, medical device, and pharmaceutical industries

• Implements new programs, tests, methods, instrumentation, and procedures.

• With minimal supervision, plans and performs experiments that support new product or technology feasibility testing. Develops new methodologies or conducts routine procedures as needed.

•  Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs, and performs testing of product produced experimentally as required.

• Acts as liaison with machine makers, vendors, or other 3rd party entities:

• Establishes working relationships with external technology partners

• Maintains technical relationships with major equipment/machine makers, vendors, or other 3rd party entities

• Effectively communicates, orally and written, project progress and results both within the team and to the customers

• Skilled in effectively presenting/communicating performance results/test outcomes

• Clearly understands how to assimilate large amounts of data into understandable and concise presentations

• Demonstrates superior planning and organization skills to balance a multitude of projects and clients simultaneously

• Capable of translating activities and tasks into an actionable plan

• Effectively communicates timely, accurate and reliable reporting on progress against project deliverables

• Provides guidance to lab staff when needed

• Understands documentation requirements per cGMP

• Able to troubleshoot and provide technical assistance for Root Cause Investigations

• Supports the Services Technology Development Manager, as needed

• Performs other duties as required.

Required Skills/Experience

• Degree in Engineering or related technical field with experience supporting medical device or combin