V&V Engineer I
Principle Responsibilities: (essential job duties and responsibilities)
- Generate design verification and stability project plans
- Partner with Quality to identify/ explore areas of reliability, risk, and sampling for each assigned project.
- Develop test strategies to determine the best means of providing design verification and reliability.
- Develop stability strategies to determine best means of determining material degradation over time
- Validate test methods using equipment qualification, software validation, DOE, and measurement analysis.
- Develop and qualify new test protocols, ensuring that test objectives are effectively incorporated. Design and coordinate the fabrication of unique test fixtures required for protocol execution.
- Serve as technical expert, mentor, and peer reviewer for system, device and material test methods.
- Effectively execute and manage design verification and stability projects.
- Coordinate assigned projects resources (technical and equipment) maximizing test throughput efficiency
- Plan time and priorities in an effective manner to achieve all tasks assigned with the objective of assuring data integrity and compliance.
- Leading team through the variety of issues that arise during design verification projects.
- Apply design for reliability (DFR) concepts (DFMECA, FTA, etc) during the product development process to ensure that designs are intrinsically reliable.
- Write test reports that summarize the compilation and analysis of basic reliability data from field studies.
- Analyze test data for conformance to pre-determined acceptance criteria and prepare formal reports and results summaries.
- Assist engineering team in failure investigations/ root cause analysis for problems identified during lab testing and field issues.
- Work with lab technicians, both internal and external, to execute and troubleshoot product testing
- Use problem solving skills: 5Ms, 5 Whys, Gage R&R, etc. to determine root cause.
Skills and Experiences:
- Strong technical writing skills
- Good communication skills to convey complex technical information effectively to internal and customer stakeholders
- Need to clearly articulate design verification and stability process concepts to the business community through written and oral presentations.
- Computer skills sufficient to retrieve, manipulate, analyze, interpret, and present data.
- Be part of the solution – to maintain compliance and help manage design verification & packaging testing projects
- Understand regualtory requirements for electronic medical device and product stability to lead project team through technical challenges
- Knowledge of FDA design control requirements
- Project management experience interfacing with multiple departments
- Demonstrate ability to condense complex requirements into specific and measureable test objectives.
- Proficiency with MS Office business software – Word, Excel, Project, Visio
- Strong technical writing skills
- BS or higher in Packaging engineering
- Knowledge of international medical device standards
- Experience with solid modeling and engineering drawing creation (SolidWorks preferred).
- Strong risk management skills
- Knowledgeable of statistical software, preferably MiniTab.
- Experience in any of the following test categories: thermal, vibration, HALT, electrical safety (EG/ UL/IEC standards particularly IEC 60601).
- BS in Engineering
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor