Senior Manufacturing Engineer - Medical Devices Biomaterials

dsm-firmenich; Pennsylvania, United States, Northern America, Americas; Hybrid; USD 87,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Global collaboration

Healthcare benefits

Job summary

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

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

Qualifications

• Minimum 6 years of engineering experience in medical devices or a regulated manufacturing environment.
• Experience with process development, scale-up, and commercialization; PSM and clean room familiarity is a plus.
• Strong knowledge of DOE, statistical analysis, Lean Six Sigma, and problem-solving methodologies.

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

Engineering experience

Regulated manufacturing

PSM experience

Clean room experience

DOE & Lean Six Sigma

Cross-functional leadership

Statistical analysis

Bachelors/Masters in Engineering

Education

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

Job description

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

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