Senior Manufacturing Engineer

Position Overview:

The Senior Manufacturing Engineer will play a critical role in supporting the manufacturing operations of our medical device products. This individual will lead process improvement initiatives, manage introduction of new products, and ensure compliance with all relevant quality and regulatory requirements. The ideal candidate possesses a strong engineering background, excellent problem-solving skills, and a proven track record in medical device manufacturing.

Key Responsibilities:

• Lead and manage engineering projects related to new product introductions, process improvements, and technology transfers.

• Develop, implement, and optimize manufacturing processes to ensure product quality, efficiency, and cost-effectiveness.

• Collaborate with cross-functional teams including R&D, Quality, Regulatory, and Operations to ensure successful project delivery.

• Troubleshoot and resolve manufacturing issues, applying root cause analysis and corrective/preventive actions (CAPA).

• Prepare and review validation protocols and reports (IQ, OQ, PQ) for processes and equipment.

• Support continuous improvement activities (Lean, Six Sigma) to drive operational excellence in the manufacturing environment.

• Author and maintain technical documentation, including work instructions, process flow diagrams, and risk assessments.

• Ensure all processes and equipment meet regulatory requirements for medical device manufacturing (ISO 13485, FDA, etc.).

• Mentor and coach junior engineers and technicians.

Qualifications & Experience:

• Bachelor’s or Master’s Degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).

• Minimum 5+ years’ experience in a manufacturing engineering role within the medical device or regulated healthcare industry.

• Strong knowledge of medical device quality systems and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).

• Experience with process validation, statistical analysis, root cause analysis, and lean manufacturing.

• Proven project management skills.

• Excellent communication, teamwork, and leadership abilities.

• Proficient in use of engineering and office software (e.g., SolidWorks, Minitab, MS Office Suite).

Preferred:

• Six Sigma Green Belt or Black Belt certification.

• Experience working in high-volume manufacturing.

• Prior experience in product transfers or scale-up in a regulated environment.