Engineer 2, Combination Product Testing

About the role

Job Title: Engineer 2, Combination Products
Reporting Structure: As per current organizational chart
Position Summary: As part of the BD/ZebraSci Combination Product Services team, the Engineer 2, 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.

Responsibilities

• 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
• Edits on technical aspects of combination products and testing services as appropriate
• 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
• 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
• 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
• 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
• Serves as liaison with machine makers, vendors, or other 3rd party entities
• Supports the Services Technology Development Manager, as needed
• Performs other duties as required

Qualifications

• Degree in Engineering or related technical field with experience supporting medical device or combination product testing. Will consider 7+ yrs experience within Combination product testing in lieu of education
• 4+ yrs in test method development/validation, experimental design, bench testing, data analysis, and troubleshooting
• Knowledge of cGMP requirements and ability to support root cause investigations while working effectively across cross-functional teams

Skills

• Experience with Container Closure Integrity (CCI) testing, drug-device combination products, injectable delivery systems, or pharmaceutical testing environments
• Hands-on experience with fixture design, laboratory instrumentation, and implementation of new testing technologies
• Knowledge of FDA, ISO, USP, and combination product regulations and standards
• Customer-facing technical experience with project management, technical presentations, and client support

Benefits

Annual Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance

Pay

Salary or hourly rate ranges are determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Schedule

At BD, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.