Title: Principal Engineer

　　Location: Boston, MA

　　Start Date: ASAP!

　　Duration: Direct Hire

　　Degree:

　　Minimum of a BS degree in Engineering field (Mechanical, Biomedical / Bioengineering, Chemical, Materials Science)

　　Experience:

　　7-10+ years relevant experience with Medical Device FDA and ISO13485 Quality Systems (7 yrs. would be the sweet spot)

　　"Must Haves":

　　CAPA Owner and Investigator experience

　　-Good Technical & Project Management skills

　　-Excellent Design File experience

　　Experience in Statistical Study Design (DOE, Regression Analysis, ANOVA, etc.)

　　Lean Six Sigma Green Belt Certification

　　In-depth knowledge of materials, manufacturing and processing methods for medical device disposables

　　Experience in Design for Reliability and Manufacturability or Design for Six Sigma (DFRM / DFSS)

　　Duties/Responsibilities:

　　Providing technical and project leadership directing initiatives of varying size, scope, and complexity with effective management of project Scope, Time, Budget, and Communication

　　Leads CAPA root cause investigations on design-related issues, develops business-centric corrective and preventative actions, manage action effectiveness, and be responsible for quality record documentation

　　Experienced leadership role where skills in problem-solving, stakeholder management, communication, and aligned autonomy are required

　　It is a “role-modeling” position that demands not only expertise in execution, but strategic leadership skills

　　Will be responsible to act as the lead design engineer on Disposables R&D projects

　　Will lead R&D efforts relating to product sustaining and life-cycle management for clients Disposable products, including CAPAs, SCNs, and Design-related initiatives and programs

　　Working knowledge of Medical Device Design Control including active management of Design History File elements.

　　Manages approvals of Disposable designs with Computer Aided Engineering (CAE) tools and oversee Geometric Dimensioning and Tolerancing (GD&T) design evaluations.

　　Manages design-related changes promoting a disciplined approach to Change Control Methodology.

　　Manages Supplier Change Notifications and works with procurement teams on design-related initiatives.

　　Provides technical leadership, trains, mentors, and takes initiative to assist junior staff and others. Troubleshoots complex problems and engages others in problem solving strategies to obtain practical and effective solutions to complex issues. Evaluates applicability and impact of technical methods and solutions referred by junior staff

　　Independently researches issues outside technical capability and selects most efficient methods/techniques to achieve objectives. Applies appropriate standards, processes, policies, procedures, practices and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s), and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems

　　Develops and analyzes statistical study designs (DOE, ANOVA, etc.) for feasibility and design verification of disposables.

　　Collaborates and interfaces extensively within and outside R&D. Works effectively with multiple diverse technical and business functions and uses tact and discretion to resolve conflicts

　　Experience with operating and managing teams within a Global R&D organization

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.