Sr Manufacturing Engineer

Essential Functions

• Process Optimization – Improve manufacturing processes for efficiency, cost-effectiveness, and product quality.
• Regulatory Compliance – Ensure adherence to industry regulations (e.g., FDA, ISO 13485).
• Cross-functional Collaboration – Work with R&D, quality, and supply chain teams to streamline production.
• Troubleshooting – Solve complex manufacturing issues and lead root cause analysis.
• Team Leadership – Mentor and guide junior engineers and production staff.
• Cost Management – Develop and maintain budget controls while ensuring quality standards.
• Technology Integration – Implement automation and advanced manufacturing technologies.

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
Occasional lifting up to 50 lbs., occasional heavier lifting.
Occasional pushing, pulling and handling of materials.

Required Education And Experience

• Bachelor’s Degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
• 5-10 years of experience in manufacturing engineering, preferably in the medical device or healthcare industry.
• Strong experience with manufacturing processes, such as CNC machining, injection molding, assembly and/or automation.
• Experience with regulatory standards such as FDA (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
• Proven track record of process optimization, cost management, and quality improvement.
• Experience in leading cross-functional teams and collaborating with R&D, quality, and supply chain departments.
• Familiarity with CAD software (e.g., SolidWorks, AutoCAD) for designing or modifying production equipment and tools.
• Hands-on experience with root cause analysis and problem-solving techniques (e.g., Six Sigma, Lean).

Preferred Education And Experience

• Master’s Degree in Engineering or Business Administration.