Senior Validation

About Us

At embecta, we're a global diabetes care company that's leveraging our 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions and partnerships.

We value diversity, equity, and inclusion, and we strive to foster an inclusive culture where everyone feels valued and empowered to bring their authentic self to work.

Total Rewards Program

• Competitive pay
• Benefits
• Continuous learning
• Recognition
• Career growth and development
• Life balance components

Job Summary

The Senior Engineer, R&D - Verification and Validation, is accountable for the execution of design verification and design validation testing in support of product lifecycle management and new product development.

Main 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 and changes to existing products.
• Drafts engineering technical reports, test method work instructions or procedures, and test method validation-related documents.
• Lights up and 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.
• 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).
• Oversight of test methods and ensuring equipment is validated per business requirements.

Education & Experience

• Minimum of Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related field.
• 8+ years of professional experience in the medical device, pharmaceutical, or life sciences field.
• Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.).
• Experience with executing Design Verification and/or Design Validation on a mechanical or electromechanical medical device.
• 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.
• Practical experience with implementing product changes through a structured, phase-gated product development process within a regulated framework.
• Experience solving problems, providing detailed insight, and constructive criticism in complex situations, and foreseeing problems along with potential solutions.
• Working knowledge of applicable medical device regulatory standards.

EEO Statement

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.