Principal Test Engineer NPI - Merz North America, Inc

Principal Test Engineer is an R&D product development, manufacturing, and process development skilled individual assigned work related to manufacturing integration of medical devices from concept to start-up manufacturing. This individual will be involved in all phases of product development as a key contributor representing product development and manufacturing. They will also own and drive efforts working with internal and external partners/teams to develop testing, test equipment, protocols, product specifications, and other required documentation, to validate both design and manufacturing test processes, through to commercial launch of new products.

Responsibilities 

• Draft and manage the release of test plans for design verification and design validation of medical devices.
• Draft and manage the release of test plans for process validations including final reports of medical devices.
• Write and Revise test requirements
• Perform test failure analysis, troubleshooting of electromechanical systems such as mechanical mechanisms, components, and printed circuit boards.
• Work with external test suppliers and partners to develop testing methodology to meet specifications and requirements.
• Use statistical data to derive test conclusions
• Provide audit support qualifying external test houses
• Provide input to User Requirements and System Requirements Documents.
• Conduct/Support Design/Process FMEA to evaluate potential failures and implement risk mitigations
• Product Transfer of Design to Production, including Warehousing and Service & Repair criteria documentation.
• Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
• Support the design for testability efforts on new product introduction as we as making recommendations on existing designs.
• Provide technical guidance on standards interpretation and specific applicability to new products.
• Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
• Champion problem solving and root-cause analysis efforts as it relates to electric/electronic test failures.
• Support products pre and post market as part of the engineering team to develop test plans, methods, protocols, and reports while improving existing test methodologies for product evaluations and analysis.
• Collaborate with R&D, Quality, Manufacturing, SMEs and Regulatory to ensure the testing of a product is defined appropriately, including test fixturing, for test reliability and manufacturability.

Education

• Bachelor’s Degree in ME or EE or other relevant Engineering discipline required
• MBA / Master’s in ME or EE or other relevant Engineering discipline preferred

Professional Experience

• Minimum 12 years’ experience as a test engineer or testing role in the medical device and/or component industry
• Design Control experience including design and process verification and validation
• Experienced in using LabVIEW, including Test Stand
• Experience with testing of electro-mechanical and/or electrical systems in a production environment

Knowledge, Skills, and Abilities

• Familiarity with coding in C/C++ (including MS Visual Studio C++ 2010 or newer)
• Familiar with project management methods and tools

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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 CFR 60-1.35(c) Research and Development