Senior Engineer, R&D - Verification and Validation

My client is looking for a Senior Engineer, R&D - Verification and Validation

Location – Massachusetts – United States
Salary $130k - $150k & Benefits Package
Industry – Medical Device

My client is searching for a Senior Engineer, R&D - Verification and Validation to be part of a team focused on product development of complex, new-to-world product development platforms that help people with diabetes live healthier lives. We are looking for a highly driven individual, with a passion for problem solving and a proven track record of successfully developing and qualifying test methods and executing design verification and validation testing of electromechanical medical devices. Reporting to the Sr. Manager, R&D – Verification and Validation, the successful candidate will be responsible for executing product design verification and validation activities, including test method or measurement system development, test fixture design and test system hardware/software validation. They will ensure that translated product requirements are testable and measurable. The ideal candidate will also participate in executing technical and cross-functional project work, which includes all phases of product development, including design and development planning, requirements definition, product development, root cause analysis and product reliability.

Job Description

Responsibilities include but not limited to the following:

• Develops and optimizes physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products
• Performs hands-on and simulated testing for design verification and test method developments
• Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents
• Leads/executes test method validation (TMV), design verification tests, and test method transfer, in support of regulatory submissions and commercialization of new products
• Establishes test system software requirements (SRS) and supports execution of test system software validation in support of product design verification
• Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
• Applies sound engineering principles and practices to the design and testing of medical devices
• Interacts with external development partners and equipment suppliers, Operations, Quality, and IT/Infrastructure groups to achieve design verification and validation deliverables
• Executes routine and non-routine mechanical and analytical testing to support the development, verification or validation of new products
• Supports the R&D team in data review, analysis, and interpretation. Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)

Minimum Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering or related field
• 5+ years of professional experience in the medical device, pharmaceutical or life sciences field
• Applied experience in developing and qualifying electromechanical test systems or test methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.)
• Applied experience in test system software validation (Computer Systems Validation or CSV) per regulatory requirements and industry best practices
• Experience with executing Design Verification and/or Design Validation on a mechanical or electromechanical medical device
• Practical experience with implementing product changes through a structured, phase-gated product development process within a regulated framework
• Demonstrable proficiency in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, etc. using Minitab, SAS or similar data analysis packages
• 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 knowledge of applicable medical device regulatory standards i.e.: FDA 21CFR 820,  ISO 13485, ISO 11607, IEC 60601, ISO 10993, ISO 14971, etc.

Desired Qualifications: 

• Graduate degree (MS or PhD) in Engineering or related field
• 8+ years of post-educational experience in Medical Device Design highly desired
• Six Sigma certification training / experience
• Applied experience with developing and optimizing Matlab (preferred), Python or R Scripts for complex data analysis
• Drug delivery or combination medical device development experience highly desired
• Proficiency with advanced statistical techniques; including Reliability Testing & Analysis, Analysis of Variance (ANOVA) and Design of Experiment (DOE)
• Expertise in common risk management techniques, e.g.: FTA, FMEA, Hazard Analysis, etc.

Knowledge, Skills and Abilities:

• Ability to manage competing simultaneous priorities effectively
• Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements including design control. This includes understanding of phase gate process.
• Demonstrated deep understanding of establishing project and product requirements
• Highly collaborative both within the function and with other functions
• Advanced technical and managerial judgment; advanced problem-solving skills
• Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally
• Self-initiator, results driven and action & detail oriented
• Disciplined and well organized
• Ability to travel approximately 25% of the time, and international travel may be required