Senior Engineer, R&D Verification and Validation

embecta • Andover, MA

3d • Onsite

About The Position

The Senior Engineer, R&D Verification and Validation, is accountable for the execution of design verification or design validation testing in support of new product development for complex electromechanical medical devices. Reporting to the Associate Director, R&D Verification and Validation, the successful candidate brings prior electromechanical medical device R&D or design quality assurance experience within the New Product Development (NPD) environment, to facilitate successful regulatory submissions of candidate product designs, in the US as well as other geographical regions.

Requirements

• 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
• 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 authoring Design Verification test plans and/or protocols per regulatory and Quality System requirements
• Experience with executing Design Verification and/or Design Validation on a mechanical or electromechanical medical device
• 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.)
• 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
• Working knowledge of applicable medical device regulatory standards i.e.: FDA 21CFR 820, ISO 13485, ISO 11607, IEC 60601, ISO 10993, ISO 14971, etc.

Nice To Haves

• 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
• Prior experience with executing mechanical safety testing per IEC-60601-1, IEC-60601-2-24 and related collateral standards, working with external test houses.
• 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.

Responsibilities

• Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products.
• Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents
• Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation
• Authors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality System (QS) and regulatory requirements
• Manages and tracks product configurations through design verification and validation, including Hardware/Software/Firmware version tracking, to allow for determination of impact due to configuration changes
• Performs hands-on and simulated testing for design verification and test method developments
• Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
• Interacts with external development partners and equipment suppliers, Operations, Quality, and IT/Infrastructure groups to achieve design verification and validation deliverables
• 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)

Benefits

• For certain roles at embecta, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with Client's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior