Staff Research Development Engineer

4 days ago

Andover, Massachusetts, United States Indotronix International Corporation Full time
Job Title: Senior Engineer - R&D Verification and Validation

Location: Onsite

Status: Full-time, Salaried, Direct-Hire employee

Work Style: Onsite

Job Summary:

We are seeking a highly skilled Senior Engineer - R&D Verification and Validation to lead the design verification or design validation of electromechanical medical devices developed by Indotronix International Corporation. The successful candidate will bring prior electromechanical medical device design, development, and qualification experience and a passion for delivering innovative, cost-effective, and reliable medical device solutions to our customers.

Key Responsibilities:

  • Collaborate as a key member of the R&D, Systems, and V&V teams to ensure that product requirements are relevant, testable, and measurable.
  • Define, plan, and lead activities, including test method & measurement system development and validation, fixture design, and testing optimization in support of Design Verification or Design Validation.
  • Author and execute Design Verification plans or protocols to ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements.
  • Define and lead 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.
  • Lead the execution of IEC 60601 mechanical safety testing relevant to the product profile, working with external lab vendors to ensure appropriate product certifications.
  • Ensure 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.
  • Author Design Verification test reports to support regulatory submissions for new products, derivative products, or regulatory approvals to expanded geographical regions.
  • Implement 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.
  • Synthesize, develop, update, and optimize 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.

Requirements:

  • 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 in order to make regulatory submissions (US -FDA or other geographic region agencies).
  • Experience with defining and executing testing regimen 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 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, 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 is highly desired.
  • Experience as lead in the development of medical disposable devices is highly desired.
  • Experience with software or firmware development compliant with IEC 62304 is highly desired.
  • Six Sigma certification training/experience.
  • Pharmaceutical Infusion pump development experience.
  • Expertise in common risk management techniques is 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, and 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.

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