Job Title: Manufacturing Engineer – Medical Automation & Injection Molding
Job Description
We are seeking a skilled Manufacturing Engineer with expertise in medical device manufacturing, automation, injection molding, and APQP processes. The role will focus on supporting production, improving manufacturing processes, and ensuring compliance with regulatory and quality standards. This position requires strong problem-solving, cross-functional collaboration, and hands-on engineering skills to optimize manufacturing operations.
Key Responsibilities
- Develop, implement, and optimize manufacturing processes for medical device production, with emphasis on automation and injection molding.
- Apply APQP (Advanced Product Quality Planning) methodologies to ensure robust process development and launch readiness.
- Design and validate manufacturing fixtures, tooling, and equipment to improve efficiency, quality, and throughput.
- Collaborate with R&D, Quality, and Production teams to support new product introduction (NPI) and transfer projects.
- Lead process validation activities, including IQ, OQ, PQ protocols, ensuring compliance with ISO 13485, FDA, and other applicable regulations.
- Identify root causes of process and product issues using structured problem-solving tools and implement effective corrective and preventive actions.
- Drive continuous improvement initiatives to reduce cost, scrap, and cycle times while maintaining product quality.
- Maintain documentation including work instructions, PFMEA, control plans, and process flow diagrams in alignment with APQP standards.
- Provide technical support for manufacturing operations, training production staff, and ensuring smooth day-to-day operations.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field.
- 2–6 years of experience in medical device manufacturing, automation, or injection molding.
- Strong knowledge of APQP, PPAP, FMEA, and Six Sigma tools.
- Hands-on experience with injection molding processes, equipment setup, troubleshooting, and validation.
- Familiarity with medical device regulations (ISO 13485, FDA 21 CFR Part 820).
- Proficiency in CAD software (SolidWorks, Creo, or equivalent).
- Strong analytical, organizational, and communication skills.
Preferred Skills
- Experience with robotics, automated assembly, and vision systems.
- Lean Manufacturing and Six Sigma certification (Green Belt or higher).
- Knowledge of GD&T, tolerance stack-up, and mechanical design principles.
