Staff Engineer, R&D – Verification and Validation

My client, a leading medical device company, is offering an exciting opportunity for a Staff Engineer, R&D – Verification and Validation. This role is the technical lead in the design verification or design validation of electromechanical medical devices. Reporting to the Associate Director, R&D – Verification and Validation, the successful candidate will have the chance to lead technical projects and bring their prior electromechanical medical device design, development and qualification experience to deliver innovative, cost-effective and reliable medical device solutions to their customers.

The responsibilities of the Staff Engineer, R&D-Verification and Validation, are diverse and challenging. They include but are not limited to the following:

• As a vital member of the R&D, Systems and V&V teams, the Staff Engineer, R&D-Verification and Validation, will play a crucial role in ensuring that product requirements are relevant, testable and measurable. This collaborative approach underscores the importance of teamwork and the opportunity to work with diverse teams.
• Defines appropriate regression testing or incremental test plans with rationales for engineering changes to previously verified designs.
• Works with contractual laboratory partners to define and execute tests per applicable safety and compliance standards, including but not limited to ISO 10993 standards for biocompatibility, transportation and distribution testing per ASTM D4332 and ASTM D4169 standards.  
• Led the execution of IEC 60601 mechanical safety testing relevant to the product profile, working with external lab vendors to ensure appropriate product certifications.
• Defines, plans, and leads activities, including test method and measurement system development and validation, fixture design, and testing optimization, in support of Design Verification or Design Validation.
• The successful candidate will provide crucial input on relevant safety and compliance standard requirements for new product development projects (NPD), contributing to the creation of innovative and groundbreaking medical devices.
• Authors and executes design verification plans or protocols to ensure design input requirements are satisfied with all relevant quality system and regulatory requirements. 
• Defines and leads the execution of a suitable product reliability test plan to critically evaluate system performance and reliability, ensuring that the product is adequately pressure-tested to satisfy user, regulatory and business requirements.  
• Ensures Design Verification testing is performed with sample sizes that meet the requisite confidence level and reliability, proportional to the risk assessed for the relevant design inputs. 
• Authors design verification test reports to support regulatory submissions for new products, derivative products, or regulatory approvals for expanded geographical regions. 

Minimum Qualifications:

• Bachelor’s degree in mechanical engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering or related field.
• 10+ years of professional experience leading or supporting product development projects, including electrical and mechanical systems.
• 5+ years of experience with leading or executing Design Verification of disposable electromechanical medical devices that include Hardware/Firmware/Software (App) interfaces.
• Practical experience with various elements of the New Product Development (NPD) process; including design lifecycle phases and product design qualification in support of regulatory submissions (US -FDA or other geographic region agencies).
• Experience with defining and executing testing regimen to demonstrate compliance with IEC 60601 for mechanical and electrical safety.
• Demonstrated experience with developing and executing product reliability test plans for both durable and disposable medical devices.
• Experience with implementing product changes through a structured, phase-gated product development process that compiles with FDA regulations for Design Control.
• Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
• Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions.
• Leadership and team building skills.
• Working with regulatory standards.
• Strong project management skills.