Electrical Test Engineer

NxStage Medical, Inc. 20 reviews - Lawrence, MA

Position Summary:
The individual in this position will support product development and lead test-
related activities related to the development of NxStage Medical�s equipment and
disposable products.

Core Responsibilities:
Work closely with all engineering disciplines, including Systems, Electrical,
Mechanical, Disposables, and Software Engineering, as well as Project Management
and Quality personnel, to verify and validate product designs.
Participate in the planning and lead the execution of Validation & Verification
(V&V) testing activities in support of regulatory filings for Class II medical
devices.
Specify, design, and develop test systems (hardware & software); ensure that all
test systems and equipment are appropriately validated and controlled.
Manage V&V documentation, including derivation of Test Procedures from System and
Sub-System Specifications, validation of Test Procedures and Test Fixtures, and
generation of test reports.
Lead the design, fabrication, and validation of electromechanical test fixtures.
Supervise individuals conducting testing to ensure proper execution of test methods
and test reporting.
Perform verification and validation testing, track and report on progress, ensure
V&V test completion, review data, and document conclusions.
Work with Quality Assurance and Development teams to maintain an approved internal
Quality System that meets the requirements of GMP�s, QSR and ISO 9001.

Requirements:
B.S. degree in an Engineering or related technical discipline PLUS 1-3 yrs
experience, or Associates degree in a technical field PLUS 5+ yrs experience.
Experience with V&V testing and product development per FDA design controls and
ISO13485.
Hands-on experience with standard test instrumentation, DOE, V&V testing,
designing, building, and maintaining test fixtures.
Experience creating verification and validation plans, protocols, and reports.
Experience with requirements management, risk-based testing approaches, defect
tracking and resolution.
Demonstrated ability to manage multiple tasks and priorities simultaneously and
adapt to changes in program priorities.
Excellent written and verbal communication skills.
Advanced knowledge of statistical testing and analysis methods.
Technical understanding of product design and development methodologies.
Advanced understanding of entire medical device product development process,
including the preparation of specifications, working under design controls,
documentation, and quality assurance.

Desirable Skills:
Experience with automation tools for testing applications (LabView, Matlab).
Working knowledge of Solidworks,; Minitab a plus.
Design for Test (DTF) knowledge / experience.