Verification & Validation Engineer
About the Opportunity
We are seeking a Verification and Validation Engineer to work in our corporate office, located in Bethesda, MD. The ideal candidate will have a system or software testing background, medical device industry experience, and ability to coordinate and manage product verification validations across the company. This position requires software test experience, technical expertise in medical device and information system design and development, as well as knowledge of quality and regulatory requirements.
- Reports to Quality Assurance Manager
- Full Time position
- Competitive salary, stock option package and strong benefits
- Lead the verification and validation strategy/planning/scheduling efforts as the Product Qualification cross-functional representative.
- Review product, user and technical system requirements for completeness, feasibility and testability of the product and/or system.
- Support Software Release processes and documentation, including execution of software verification protocols as part of each release, develops bug-tracking reports and documentation.
- Propose and implement automated testing methods and procedures for manufacturing processes, verification and validation testing in a DevOps environment
- Define and implement system integration and test protocols (including embedded, mobile and web services software, as well as electrical and mechanical systems).
- Design and develop repeatable test methods/procedures and automated scripts for product & system verification, considering both requirements-based and clinical and business use case-based approaches
- Define and implement system verification and validation protocols, sampling rationale and acceptance criteria in coordination with engineering and research teams, and create associated documentation (plans, protocols and reports) that comply with US and international medical device regulations and corporate quality management systems procedures.
- Plan, develop and execute test protocols to ensure product safety and effectiveness appropriate to the stage of development for the device, encompassing software, hardware and system level components.
- Continually “stress test” and use the device(s) to identify design and/or manufacturing issues prior to product release.
- Troubleshoot and provide technical assessments of issues encountered internally or by customers in existing products covering multiple domains (e.g. analog, digital and/or software) and effectively collaborate cross-functionally on system level issues.
- Assist in the design and implementation of proof-of-concept simulations and/or prototypes.
- Contribute to error budgeting, reliability analysis, design for manufacturability, and design for cost programs.
- Assists in writing and coordinating the submission of Regulatory documents to FDA and other Regulatory Agencies, including International Documents (e.g., technical files).
- Work within timelines, resources, and budgets for completion of assigned projects.
- Provides technical leadership on various engineering projects and/or sub-projects.
- Other tasks and responsibilities as assigned.
- Bachelor’s and 3+ years’ experience or Master’s and 1+ year experience in Software, Computer Science, Systems, Biomedical, Electrical, Mechanical or other Relevant Engineering discipline is required.
- Knowledge of and experience with medical device standards such as IEC 62304, IEC 60601, ISO 13485 and ISO 14971.
- Working knowledge of product development life cycle in regulated medical device environment.
- Experience with software testing.
- Expertise or working knowledge of medical device software quality assurance across range of platforms (Mobile, Embedded, PC and Web).
- Proficient with the use of MS Office Products (Word, Excel, PowerPoint SharePoint).
- Good organizational skills.
- Experience with systems engineering processes.
- Demonstrated experience working with and testing electronic products, including software.
- Ability to troubleshoot device problems to the circuit board level using schematics, oscilloscopes, multi-meter, and other standard laboratory test and measurement equipment.
- Familiarity with Linux and Android development tools and environments, JUnit test development, scripting (Bash/Python) and/or coding experience a strong positive.
- Strong written, verbal, and interpersonal skills.
- Flexibility, willingness to learn, and a demonstrated ability to come up to speed quickly on new technologies and technical issues.
- Ability to operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development.
- Comfortable working in a fast-paced entrepreneurial culture.
- Experience with medical devices performing real-time data acquisition.
- Experience with EEG systems is strongly preferred.
- Beneficial hardware expertise: Wireless (RF) communication standards, analog and digital circuit design and Bio-electrical interfaces.
- Knowledge of SolidWorks, LabVIEW and Matlab a plus.
Qualified applicants are encouraged to send their resume and a cover letter including availability to firstname.lastname@example.org.
The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at http://www.dol.gov/ofccp/regs/compliance/sec503/Voluntary_Self-Identification_of_Disability_CC-305_SD_Edit1.24.14.pdf