Senior Engineer - Combination Products & Test Methods

bdx; Branchburg Township (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Annual Bonus

Health benefits

Life insurance

Paid time off

Job summary

BD in New Jersey seeks a Combination Products Senior Engineer (JG4) to lead test method development and validation for drug-device products. You will serve as a technical expert to pharmaceutical customers and ZebraSci lab operations, guiding fixture design, data analysis, and method implementations.

You’ll oversee root-cause investigations, teach teams, and collaborate with cross-functional groups to ensure cGMP-compliant results and effective customer solutions.

Qualifications

• Bachelor’s degree in science or engineering and 5+ years’ experience in Drug Device Combination Product or Medical Device development or testing (Master’s +3 years).
• Technical leadership to support clients and mentor teams.
• Strong regulatory data analysis and statistical approaches knowledge.
• Experience with mechanical measurement equipment, vision systems, and container closure instrumentation.
• Understanding of ISO 11608, 11040, 13485 regulatory requirements.
• Experience with testing methods development, validations (MSA, Gage R&R).
• Proficiency in CAD (SolidWorks) for fixture design and GD&T for engineering drawings.
• Experience writing programs on Instron, Zwick, Keyence, etc.

Responsibilities

• Contribute to customer sales process and service delivery with a client-first mindset.
• Translate customer requests into technical responses, solutions, and action plans with minimal supervision.
• Educate customers and internal teams on technical aspects of combination products and testing services.
• Lead scoping of testing approaches, fixturing, protocols, and method validation.
• Coordinate with cross-functional teams to resolve challenges and provide updates.
• Develop training materials and technical documentation as needed.
• Maintain and diffuse combination product services technology and instrumentation.

Skills

Technical leadership

Data analysis

Regulatory awareness

Measurement equipment

Vision systems

CAD/SolidWorks

GD&T knowledge

DOE/ANOVA statistics

Instron/Zwick/Keyence

Education

Bachelor’s or Master’s in science/engineering

Tools

Instron

Zwick

Keyence

SolidWorks

Job description

BD in New Jersey seeks a Combination Products Senior Engineer (JG4) to lead test method development and validation for drug-device products. You will serve as a technical expert to pharmaceutical customers and ZebraSci lab operations, guiding fixture design, data analysis, and method implementations.

You’ll oversee root-cause investigations, teach teams, and collaborate with cross-functional groups to ensure cGMP-compliant results and effective customer solutions.