Senior Process Engineer - Manufacturing Excellence and NPI

Smith+Nephew; New York (NY); Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

Hybrid work model

401k matching

Tuition reimbursement

Paid holidays

Volunteer time off

Job summary

Smith+Nephew is seeking a Process Engineer 3 in New York to drive continuous improvement, support new product introductions, and ensure manufacturing processes and equipment meet the highest quality and regulatory standards.

You will lead process improvements, qualification activities, change controls, CAPAs, and cross-functional projects to deliver cost savings and successful commercialization.

Qualifications

• Bachelor’s degree in Engineering or Life Sciences.
• 3+ years of manufacturing or process engineering experience in an FDA-regulated environment.
• Proficient in MS Office (Word, Excel, PowerPoint).
• Strong verbal and written communication in a multi-disciplinary team.

Responsibilities

• Lead the development and implementation of manufacturing process improvements and production controls.
• Drive risk assessments and gap assessments for current and future processes.
• Oversee equipment and process qualifications to support regulatory needs.
• Author and review change controls, validation protocols, CAPAs, and quality docs.
• Support new product transfers from development to manufacturing and commercialization.
• Qualify new manufacturing equipment and support validation activities.
• Identify and deliver cost-saving and business transformation opportunities.
• Develop user needs documentation and drive solution-driven improvements.
• Conduct R&D to evaluate feasibility of new ideas and technologies.
• Provide technical support and leadership across manufacturing operations.

Skills

Process engineering experience

Team leadership

Effective communication

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

MS Office

Job description

Smith+Nephew is seeking a Process Engineer 3 in New York to drive continuous improvement, support new product introductions, and ensure manufacturing processes and equipment meet the highest quality and regulatory standards.

You will lead process improvements, qualification activities, change controls, CAPAs, and cross-functional projects to deliver cost savings and successful commercialization.