Engineer - NPI - Merz North America, Inc

Engineer is a manufacturing and process development expert leading project work related to manufacturing integration of medical devices. This individual will be involved in all phases of product development as a key contributor representing manufacturing. Works with R&D to ensure designs are manufacturable, evaluate potential suppliers, and work with internal and external teams to develop and validate manufacturing processes.

Responsibilities

• Support/Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
• Support/Develop & define production control methods to monitor process output and establish critical supplier metrics.
• Define and coordinate the design and development of manufacturing fixturing and test equipment.
• Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
• Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
• Lead and support manufacturing development and transfers to contract manufacturers.
• Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
• Provide input to the User Requirements and System Requirements Documents.
• Conduct Design/Process FMEA to evaluate potential failures and implement risk mitigations.
• Ensure Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) for process, design and development of new and existing products.
• Identify potential suppliers and perform technical evaluation for selection.
• Support Supplier audits and qualifications.
• Teach others throughout the product development process and utilize solid problem-solving skills.
• Support other departments in engineering functions such as testing, report writing, or other activities to complete development requirements for final designs and bring product to market.

Education

• Bachelor’s Degree in ME or EE or other relevant Engineering discipliner required

Professional experience

• Minimum 3-5 years of related design and manufacturing experience in the medical device and/or component industry
• Design Control experience including design and process verification and validation         
• Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ)     
• Injection molding, die casting, metal stamping and/or machining knowledge, including fixtures gauges and tooling experience        

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          
• Understanding and application of ISO Quality System requirements and FDA regulations 
• Familiar with a variety of manufacturing processes including mechanical and electromechanical   
• Ability to work effectively with internal and external teams           
• Demonstrated ability to deliver results with minimal supervision  
• Ability to communicate cross-functionally, support the teams engineering requirements, and follow the various SOP’s to create required documentation and reports, including support and direct the efforts of junior level engineering staff          

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development