Position Summary

The Manufacturing Engineer is responsible for supporting and improving manufacturing operations through the development, qualification, implementation, and optimization of manufacturing processes, equipment, and methods. This role partners closely with Quality Assurance, R&D, and Operations teams to support new product introductions, execute process validations, lead manufacturing improvement projects, and ensure efficient, compliant manufacturing performance in an FDA-regulated environment.

Key Responsibilities

Manufacturing Engineering & Process Development

• Establish and maintain manufacturing documentation, procedures, drawings, and technical records.
• Develop, implement, and improve manufacturing processes and methods to enhance operational performance.
• Recommend, design, and implement manufacturing tooling, fixtures, and process improvements.
• Support the successful transfer of new products from R&D into manufacturing.
• Train production operators on manufacturing processes, equipment, and procedures.

Validation & Quality Support

• Develop and execute equipment and process qualifications, including IQ, OQ, and PQ validations.
• Coordinate Non-Conforming Material and CAPA activities in partnership with Quality Assurance.
• Support compliance with regulatory, quality, and manufacturing requirements.

Project Leadership

• Lead manufacturing projects and process improvement initiatives.
• Serve as project leader for product and process modifications.
• Participate in project meetings and ensure timely completion of assigned actions and deliverables.
• Support special projects and continuous improvement initiatives as assigned.

Operational & Technical Support

• Maintain technical services and facilities performance metrics.
• Prioritize equipment repair efforts to minimize manufacturing downtime when multiple issues arise simultaneously.
• Coordinate daily workflow and delegate tasks to meet operational objectives.

Team Leadership & Development

• Supervise manufacturing and engineering technicians as needed.
• Support the selection, onboarding, training, development, recognition, and performance management of team members.
• Build a highly skilled and accountable team through coaching, goal setting, mentoring, counseling, and performance feedback while maintaining appropriate records.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline with 6-8 years of relevant experience, or Master's degree in Mechanical Engineering or a related engineering discipline with 2-6 years of relevant experience.
• Experience working in an FDA-regulated manufacturing environment.
• Strong partnership and collaboration skills with Quality Assurance and R&D teams.
• Fluent English communication skills, both written and verbal.
• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience working in cleanroom manufacturing environments.
• Experience supporting liquid filling processes.
• Experience using engineering and project management software such as SolidWorks 3D CAD, Microsoft Project, or equivalent tools.

Work Environment

Travel

• Approximately 5% travel may be required.

Physical Demands

• Regularly required to stand, walk, and sit for extended periods.
• Occasionally required to lift or move up to 50 pounds.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Mental Demands

• Moderate to high degree of concentration required due to workload volume, complexity, and competing priorities.

Work Authorization

Applicants must be authorized to work for ANY employer in the United States. We are unable to sponsor or take over sponsorship of an employment visa at this time.