General Summary

The Senior Development Quality Engineer leads Quality Engineering responsibilities as part of a product development team to design and qualify new life-saving products. This role is for a fully qualified engineer in all conventional aspects and functional areas. Plan and conduct work requiring judgment and independent evaluation along with selection and adaptation or modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. Develop quality standards, application, revision, and maintenance for design, manufacturing, and inspection. Implement design control requirements and provide quality engineering support. Work independently with general instructions toward the objectives expected. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Communicate and implement quality objectives.

Specific Duties and Responsibilities

• Lead in the development and qualification activities for new and existing products.*
• Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products.  Plan, schedule, conduct, or coordinate detailed phases of engineering work for projects with various scopes. *
• Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements. * 
• Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment.
• Develop and validate measurement methods.
• Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control requirements per regulatory and industry standards
• Support developmental projects in the area of quality engineering
• Analyze reports and recommend corrective and preventive action to adverse results.
• Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications.
• Support activities during FDA inspections and notified body audits. *
• Participate in the development of standard operating procedures. *
• Develop and approve documentation for inspection/testing procedures. *
• Perform responsibilities required by the Quality System and other duties as assigned.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.

*Indicates an essential function of the role

Position Qualifications

Minimum education and experience:  

• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience 

Additional qualifications:    

• Advanced degree preferred

• Experience in auditing, design review, sterilization, project management, and/or product development highly desired 
• Demonstrated knowledge of engineering and scientific principles
• High proficiency with computers and software applications
• Medical device, pharmaceutical, biotech, and/or other regulated industry experience desired
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions

• General office, laboratory, and cleanroom environments.
• Business travel from 0% - 10%.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• Must be able to move between buildings and floors. 
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. 
• Must be able to read, prepare emails, and produce documents and spreadsheets.   
• Must be able to move within the office and access file cabinets or supplies, as needed. 
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.