Senior Manufacturing Engineer: Process Development

dsm-firmenich; Exton (PA); On-site; USD 87,000 - 110,000; Full time

Benefits offered by this job

Global reach

Professional growth opportunities

Competitive compensation

Safety culture

Job summary

dsm-firmenich Biomedical in Wayne, PA is seeking a Senior Engineer Manufacturing to provide technical leadership and drive scale-up, commercialization, and continuous improvements across new and existing product lines at our PSM-regulated facility.

You will collaborate with cross-functional teams to translate concepts into robust manufacturing processes while ensuring quality, regulatory, and safety requirements.

Qualifications

• Minimum 6 years of engineering experience in medical devices or a related regulated manufacturing environment.
• Demonstrated expertise in manufacturing processes, process optimization, scale-up, and commercialization activities.
• PSM experience and clean room experience are strong plus.
• Knowledge of engineering and quality methodologies including DOE, Lean Six Sigma, and problem-solving tools.

Responsibilities

• Lead process development, scale-up, validation, and commercialization activities for new and existing products.
• Drive improvements in manufacturing performance, productivity, quality, reliability, and cost through data-driven engineering solutions.
• Design, develop, and evaluate manufacturing equipment, tooling, automation, and machine systems to support operational excellence.
• Lead cross-functional project teams, providing technical direction, project planning, risk assessment, and progress reporting.
• Support investigations, root cause analysis, change management, and resolution of manufacturing and customer-related quality issues.
• Collaborate with Operations, Quality, Regulatory, R&D, and Commercial teams to ensure successful product implementation and lifecycle management.

Skills

Process development

Scale-up

DOE

Lean Six Sigma

Regulatory compliance

Education

Bachelor's or Master's in Biomedical, Mechanical, Electrical, Chemical, or Materials Engineering

Tools

Minitab

Statistical analysis

Job description

dsm-firmenich Biomedical in Wayne, PA is seeking a Senior Engineer Manufacturing to provide technical leadership and drive scale-up, commercialization, and continuous improvements across new and existing product lines at our PSM-regulated facility.

You will collaborate with cross-functional teams to translate concepts into robust manufacturing processes while ensuring quality, regulatory, and safety requirements.