Company Overview:
We are a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technologies. We design, develop, & manufacture high-quality medical devices that are used by healthcare professionals worldwide. Our commitment to excellence and patient safety drives every aspect of our operations, and we are looking for a talented and experienced Senior Manufacturing Engineer to join our growing team.
Position Overview:
The Senior Manufacturing Engineer will play a key role in the design, development, and optimization of manufacturing processes for our medical devices. You will work closely with cross-functional teams to ensure that our products are manufactured to the highest quality standards, meet regulatory requirements, and are produced efficiently. The ideal candidate will have extensive experience in medical device manufacturing, strong technical expertise, and the ability to drive continuous improvement initiatives.
Key Responsibilities:
- Process Design and Optimization: Lead the design, development, and optimization of manufacturing processes for new and existing medical devices, ensuring efficiency, scalability, and compliance with regulatory standards (e.g., FDA, ISO 13485).
- Troubleshooting and Problem-Solving: Identify and resolve manufacturing challenges related to equipment, materials, and processes. Provide technical support to manufacturing teams to address quality and productivity issues.
- Continuous Improvement: Drive initiatives to enhance manufacturing processes, reduce costs, improve quality, and increase productivity through Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
- Equipment and Tooling: Evaluate, select, and oversee the installation and maintenance of manufacturing equipment and tooling. Work with suppliers and vendors to ensure proper selection, calibration, and service.
- Regulatory Compliance: Ensure all manufacturing processes comply with relevant regulatory and quality standards, including FDA, ISO 13485, and other applicable guidelines.
- Cross-Functional Collaboration: Collaborate with R&D, quality assurance, supply chain, and other departments to support product development, transfer new products to manufacturing, and troubleshoot manufacturing issues.
- Documentation and Reporting: Create and maintain process documentation, including work instructions, process flows, and equipment manuals. Prepare and present reports on key performance indicators (KPIs) to management.
- Team Leadership: Mentor and provide technical guidance to junior engineers and manufacturing staff. Foster a collaborative and innovative team environment.
- Project Management: Lead or support cross-functional project teams for product launches, process improvements, and capacity expansions. Ensure projects are completed on time and within budget.
Qualifications:
- Bachelor of Science Degree in Electrical or Mechanical Engineering field.
- 10+ years of experience in within the medical device industry.
- In-depth knowledge of medical device manufacturing processes, including injection molding, assembly, packaging, and sterilization.
- Experience with endoscopes or utereroscope is preferred
- Working with new product development
- Experience with complex medical disposable - Class II or III
- Proven experience with process improvement techniques, including Lean Manufacturing, Six Sigma, or similar methodologies.
- Excellent problem-solving, analytical, and troubleshooting skills.
- Strong project management and organizational skills.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.
- Ability to mentor and provide leadership to junior engineers and other team members.
Preferred Skills and Experience:
- Certification in Lean Six Sigma (Green Belt, Black Belt) or similar quality certifications.
- Experience with automation and robotics in a manufacturing environment.
- Familiarity with medical device sterilization methods, packaging systems, and biocompatibility testing.
- Knowledge of FDA and international medical device regulations.
