The Senior Manufacturing Engineer will play a critical role in the development, optimization, and validation of manufacturing processes for our Class II medical devices. This individual will lead projects focused on improving efficiency, reducing costs, and ensuring compliance with regulatory requirements. The Senior Manufacturing Engineer will collaborate with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to drive continuous improvement and support the successful launch of new products.

Responsibilities:

• Process Development & Optimization:
  • Develop, validate, and optimize manufacturing processes for Class II medical devices, ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
  • Conduct process capability studies (e.g., CPK, PPK) and implement statistical process control (SPC) to monitor and improve process performance.
  • Lead the design and implementation of manufacturing fixtures, tooling, and equipment.
  • Develop and maintain detailed manufacturing documentation, including work instructions, process flow diagrams, and bill of materials (BOMs).
• Validation & Verification:
  • Develop and execute process validation protocols (IQ, OQ, PQ) to ensure manufacturing processes meet established requirements.
  • Analyze validation data and generate comprehensive validation reports.
  • Support equipment validation and calibration activities.
• Project Management:
  • Lead manufacturing engineering projects from concept to completion, managing timelines, budgets, and resources.
  • Collaborate with cross-functional teams to ensure successful project execution.
  • Identify and implement process improvements to enhance efficiency, reduce costs, and improve product quality.
• Problem Solving & Troubleshooting:
  • Investigate and resolve manufacturing process deviations and non-conformances.
  • Implement root cause analysis (RCA) and corrective and preventive actions (CAPA) to prevent recurrence.
  • Provide technical support to production personnel.
• Regulatory Compliance:
  • Ensure compliance with all applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and other relevant standards.
  • Participate in internal and external audits.
  • Maintain accurate and complete documentation.
• Mentorship:
  • Mentor and provide technical guidance to junior manufacturing engineers and technicians.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Minimum of 5-7 years of experience in manufacturing engineering within the medical device industry, specifically with Class II devices.
• Strong understanding of FDA regulations (21 CFR Part 820) and ISO 13485 standards.
• Proven experience in process development, validation, and optimization.
• Proficiency in statistical process control (SPC) and process capability analysis.
• Experience with process validation protocols (IQ, OQ, PQ).
• Strong project management and problem-solving skills.
• Excellent communication and interpersonal skills.
• Experience with CAD software (e.g., SolidWorks, AutoCAD).
• Experience with lean manufacturing and six sigma methodologies is a plus.

Preferred Qualifications:

• Master’s degree in Engineering.
• Six Sigma certification (Green Belt or Black Belt).
• Experience with [specific manufacturing process, e.g., injection molding, machining, assembly].