Sr. Development Quality Engineer

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.

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

Requirements

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; Demonstrated knowledge of engineering and scientific principles; High proficiency with computers and software applications; 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; Ability to lift and move up to 25 pounds; Ability to remain stationary and use a computer or other standard office equipment for an extensive period of time each day; Ability to move between buildings and floors; Ability to read, prepare emails, and produce documents and spreadsheets; Ability to move within the office and access file cabinets or supplies as needed; Ability to communicate and exchange accurate information with employees at all levels on a daily basis

Nice to have

Advanced degree preferred; Experience in auditing, design review, sterilization, project management, and/or product development highly desired; Medical device, pharmaceutical, biotech, and/or other regulated industry experience desired

Benefits

Collaborative teamwork environment where learning is constant and performance is rewarded; Opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases; Generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s); Competitive compensation package plus benefits and equity program when applicable