Medical Device Senior Manufacturing Engineer
2 weeks ago
MetaOption LLC is seeking a highly skilled Senior Manufacturing Engineer to join our team in Boston, USA. As a key member of our manufacturing team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.
Key Responsibilities:- Develop and optimize manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.
- Produce production-level assembly and part drawings for all components and sub-assemblies.
- Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency.
- Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers.
- Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships.
- Bachelor's degree or higher in Mechanical Engineering.
- 5+ years of experience in medical device manufacturing engineering, including at least three years in new product development, design transfer to production, and validating processes.
- Excellent modeling and drawing skills using SolidWorks, including proficiency with assemblies that contain dozens of parts.
- Experience working with contract manufacturers/vendors for capital equipment, electronics testing, and/or catheter manufacturing is strongly preferred.
- Proven track record in design transfer, process validation, and knowledge of sterilizable polymers and catheter fabrication techniques.
- Technical expertise in DFM, Six Sigma, LEAN, cGMP, and process validation.
- Proficient in SolidWorks with experience in tool and fixture design.
- Highly proficient in Microsoft Office Suite and statistical analysis software like Minitab or JMP for process monitoring and improvement.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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