Biomedical Engineer - Operations

About the Company:

Family owned since 1908 Merz Aesthetics is the world’s largest dedicated medical aesthetics business.

Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.

Summary:

Engineer with excellent mechanical/electrical aptitude who is pragmatic problem-solver and innovator and who has a thorough understanding of the use of various tools and equipment for prototyping and testing, device assembly and the ability to work with everything from basic drawings to detailed 3D models.

Key Responsibilities:


* Documentation of Assembly Procedures: Draft and manage the release of work instructions, drawings, specifications and other required QMS documentation as established by the process development process in support of process development or sustaining projects.


* Support Manufacturing Suppliers: Collaborate with Contract Manufactures on continuous improvements, including component-manufacturing processes, tooling / equipment methodologies, and material properties and support Contract Manufacturers onsite, as needed.


* New Product Integration: Support product development through the assembly, modification, testing, and inspection of prototypes, product components, tool and fixture design, tooling and equipment, as well as the generation of supporting documentation, and coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.


* Quality Improvements: Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.


* Design Controls Documentation: Provide input to the User Requirements and System Requirements Documents, and ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.


* Supplier Evaluation and Selection: Identify potential suppliers and perform technical evaluation for selection.

Education:


* Bachelor’s in ME, IE, EE or other relevant engineering discipline.

– Required

Experience:


* Minimum 1-2 years of related design and manufacturing experience in the medical device and/or component industry.

– Required


* Design Control experience including design and process verification and validation.


* Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ).


* Experience with injection molding, and/or electronic assembly. 

Knowledge Skills and Abilities:


* Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis.


* Solidworks or other CAD experience.


* Familiar with project management methods and tools.


* Practical knowledge of Six Sigma methodologies.

Green or Black Belt certification.

– Preferred


* Understanding and application of ISO Quality System requirements and FDA regulations....