Combination Products Senior Engineer

Position Summary

This position is reporting to the Technology Development Manager at ZebraSci in Branchburg, NJ. As part of the BD/ZebraSci Combination Product Services team, the Combination Products Senior Engineer will lead 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 testing equipment, implements new testing technologies, leads root cause investigation activities, and serves as a technical subject matter expert on equipment and testing modalities. S/he will plan, perform and analyze bench-level engineering tests or research experiments for drug-device combination products and medical devices.

Responsibilities

• Uses technical expertise to contribute to the customer sales process, service delivery, and maintains a customer-focused outlook
• Understands the technical needs and issues that customers are facing and translates customer requests into appropriate responses, solutions, services, and action plans with little to no supervision
• Educates customers and internal team on technical aspects of combination products and testing services
• Advises on service and/or product solutions for needs and answers technical questions
• Leads and/or aids in scoping testing approaches, fixturing, protocols, and method validation
• Coordinates with cross-functional teams to resolve challenges and provide updates
• Develops training modules, videos, or other materials as appropriate
• 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
• Implements new programs, tests, methods, equipment, instrumentation, and procedures
• Interfaces with machine shop to execute fixturing development and fabrication
• 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 makers, vendors, or other third parties
• Effectively communicates project progress and results
• Skilled in presenting and communicating performance results and test outcomes
• Can assimilate large amounts of data into understandable and concise presentations
• Demonstrates superior planning and organization skills
• Capable of translating activities and tasks into an actionable plan
• Provides 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
• Assists in training activities for junior team members
• Performs other duties as required

Required Skills/Experience

• Bachelor’s degree in science or engineering discipline (e.g. mechanical, biomedical, chemical engineering) and 5+ years’ experience in Drug Device Combination Product or Medical Device development or testing, or a Master’s Degree with 3+ years of experience in the requirements listed above
• Technical leader that can support and guide clients, and mentor team members and junior associates
• Strong knowledge of regulatory standard-driven data analysis and statistical approaches
• Knowledge of operation of mechanical measurement equipment, vision systems, and container closure integrity instrumentation
• Understanding of applicable regulatory requirements for combination products (e.g. ISO 11608, ISO 11040, ISO 13485)
• Project management, prioritizing and multi-tasking skills
• Ability to effectively communicate concepts, ideas and knowledge
• Experience guiding teams to develop technical solutions to complex problems
• Experience writing programs on Instron, Zwick, Keyence, etc.
• Experience with technical document generation, execution, and reporting
• Experience with test method development and validations (MSA, Gage R&R, etc.)
• Knowledge of test fixture design and development
• Proficient in CAD (SolidWorks) for fixture design
• Understanding of GD&T for creation of engineering drawings
• Application of statistical and analytical methods such as DOE, ANOVA, and statistical software
• Superior communication skills, both written and oral

Preferred Skills/Experience

• Knowledge of small-scale filling and component assembly
• Understanding of design control and system integration
• Experience in silicone or particulate analysis
• Knowledge of 3D printers for rapid prototyping and fixture development
• Experience working in a cGMP environment