Staff Engineer, Verification and Validation

Job Title: Staff Engineer, Verification and Validation Location: Andover, MA Type: Hybrid Role (1-2 days Remote) Status: Full-time, Salaried, Direct-Hire employee Shift: 1st Vacation: PTO, Floating Holidays, and Paid Company Holidays Opportunities: Yes - Multiple areas that this individual can advance into. Description: We are currently seeking a qualified Staff Engineer specializing in Verification and Validation for a prominent Medical Device company based in Andover, MA. The successful candidate will play a crucial role in ensuring compliance with IEC 60601 standards, particularly focusing on Product Safety Standards for Medical Devices. The role demands a candidate with a minimum of 10 years of experience in a Staff Engineer position, with at least 5 years dedicated to the Medical Device Industry. Requirements: •Experience: •o 10+ years in a Staff Engineer role o Minimum 5+ years working in a Staff Eng Role in the Medical Device Industry •Industry Knowledge: •o 5 years working at a company in the Medical Device Industry (Specify qualifying company in submission notes) o Familiarity with Class 2 and Class 3 Devices; no submissions with only Class 1 experience •Technical Skills: •o Understanding of statistical analysis and engineering strategies o Completion of at least one project involving Design Validation vs Verification for Med Device Development and dissemination test validation cycle •Leadership: •o Previous experience managing a team or serving as a mentor •Other Skills: •o Well-versed to be a mentor and teach others o Experience with fusion pumps (a plus) Responsibilities: The successful candidate will be responsible for, but not limited to, the following: Collaborates as a key member of the R&D, Systems, and V&V teams to ensure that product requirements are relevant, testable, and measurable. Defines, plans, and leads activities, including test method & measurement system development and validation, fixture design, and testing optimization in support of Design Verification or Design Validation. Authors and executes Design Verification plans or protocols to ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements. 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. Leads the execution of IEC 60601 mechanical safety testing relevant to the product profile, working with external lab vendors to ensure appropriate product certifications. 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 to expanded geographical regions. Implements DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical, and analytical tools which will improve design decisions and reduce design iteration cycle times. Synthesizes, develops, updates, and optimizes designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leveraging strong engineering fundamentals and tools, and integrating manufacturing principles early in the development. 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. Practical experience with various elements of the New Product Development (NPD) process; including design lifecycle phases and product design qualification for regulatory submissions (US -FDA or other geographic region agencies). Experience with defining and executing testing regimens to demonstrate compliance with IEC 60601 for mechanical safety/essential performance. 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 complying 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, providing detailed insight and constructive criticism in complex situations, and foreseeing problems along with potential solutions. Leadership and team-building skills. Working with regulatory standards. Strong project management skills. Desired Qualifications: Graduate degree (MS or PhD) in Engineering or related field. • 10+ years of post-educational experience in Medical Device Design highly desired. • Experience as a lead in the development of medical disposable devices highly desired. • Experience with software or firmware development compliant with IEC 62304 highly desired. • Six Sigma certification training/experience. • Pharmaceutical Infusion pump development experience. • Expertise in common risk management techniques highly desired. Knowledge, Skills, and Abilities: • Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. Minitab, Matlab, etc.). • Demonstrated deep understanding of establishing project and product requirements. • Regulatory standards (21CFR 820, IEC 60601, ISO 14971, ISO 13485), and system level V&V planning and execution. • Knowledge of Design for Six Sigma (DFSS) methodology. • Excellent verbal and writing skills. • Highly collaborative both within the function and with other functions. • Advanced technical and managerial judgment; advanced problem-solving skills. • Self-initiator, results-driven, action & detail-oriented. • Disciplined and well-organized. • Demonstrated learning agility of new subject matter. • Understanding and use of an innovation process utilizing elements of search, synthesis, and select. • Strong passion for the diabetes epidemic and motivation to simplify the management of diabetes.

Created: 2026-03-07