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.
• 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.
• B.S. degree in an Engineering or related technical discipline with 1-3 yrs experience, or Associates degree in a technical field with 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.
• Experience with automation tools for testing applications (LabView, Matlab).
• Working knowledge of Solidworks,; Minitab a plus.
• Design for Test (DTF) knowledge / experience
NxStage Medical is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41
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