Senior Validation

2 weeks ago

Dublin, Ireland Embecta Full time

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. 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. 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. 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 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-gatedproduct development process within a regulated framework 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 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.

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