Senior Manufacturing Engineer - Medical Device

HireFocus Recruiting is hiring a Senior Manufacturing Engineer for a leader in the industry. In this position, you will play a pivotal role in ensuring quality, efficiency, and compliance in manufacturing processes. You will collaborate with cross-functional teams to validate processes and drive continuous improvement efforts and support production of quality products.

Responsibilities needed:

• Experience in machining and manual assembly, along with extrusion and pultrusion
• Process validation experience ensuring compliance in industry standards and regulations; ISO 13485 and FDA 21 CRF820.
• Identify, develop and implement process improvements to reduce waste and enhance efficiency while increasing productivity.
• Collaborate cross-functionally with teams in R&D, Quality, Production to ensure integration of continuous improvement.
• Utilize data driven analysis to assess process performance to improve and implement solutions
• Develop and implement quality control measures and standards to exceed customer expectations
• Provide training and guidance to production team on best practices and compliance issues.

Qualifications:

• Bachelor's degree in engineering or similar engineering degree in manufacturing
• A minimum of 5 years' experience in manufacturing preferably in Medical Device manufacturing
• ISO 13485 & FDA 21 CRF820
• Experience and knowledge in machinery like CNC, extrusion, pultrusion and manual assembly processes
• Problem solver, analytical and excellent communicator.

This company offers excellent benefits and competitive compensation!

Pay: Commensurate based on experience

HireFocus Recruiting is a full-service recruiting firm providing expertise in a diverse range of professional disciplines and industries. Services include direct hire, contract and contract to hire. Locally owned and operated in north central Indiana with services provided across the USA. Focus, dedication and passion are at the root of everything we do - we are not just connecting the dots, but building lasting partnerships with our clients and candidates. To learn more about HireFocus Recruiting, email us at HireFocus Recruiting is an equal opportunity recruiting firm. All qualified applicants will be given consideration regardless of race, color, religion, age, sex, national origin, disability status, protected veteran status, or any other characteristic protected by federal, state or local laws.

MANUFACTURING ENGINEER,ISO 13485,FDA 21/CFR 820,Waste Reduction,extrustion,Pultrusion,machining