Engineer (Product Development), NxStage Medical, Inc., a Fresenius Medical Care N.A. company, Lawrence, Massachusetts

Will participate in designing, executing, and championing research and development activities of Fresenius' medical devices.  Will be involved in quality planning, internal audits, data collection and analysis, specification development and review and design review and qualification. Will work with cross-functional teams to develop and commercialize biomedical products and to maintain high quality in the process. Specific duties will include:

• Utilizing Design Control protocols for product development.
• Supporting various projects as directed by a supervisor or delegated team leader.
• Contributing biomedical engineering ideas and potential innovations for new product development.
• Preparing and delivering presentations on biomedical and mechanical engineering projects, proposals, designs, and project progress.
• Engaging in hands-on fabrication, processing, and detailed engineering specification development for biomedical products.
• Innovating new techniques, test protocols, and writing SOPs/TMs while conducting validations.
• Setting up, adjusting and operating production equipment and analysis instruments, under supervision.
• Understanding the goals and contents of research projects, executes projects with timely deliverables.
• Maintaining good documentation practices for all data forms, protocols, engineering and feasibility reports, and laboratory notebooks.
• Participating in cross-functional teams on new product development and manufacturing problem-solving efforts.

Requirements:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Biomedical or Mechanical Engineering and experience, which can include academic internship experience and/or knowledge gained through coursework, with the following:

• Using SolidWorks and 3D modeling in the design and development of mechanical components;
• Data analysis and statistical analysts using MATLAB and Minitab;
• Performing system modeling using MATLAB and/or Simulink;
• Applying knowledge of disease and treatment modalities to the design of a medical device;
• Designing test methods for devices or projects to be used in a medical device application;
• Using 3D printing and machining processes in part design.

Salary is $86,299 – $90,614 per year for a 40-hour work week.

EOE, disability/veterans