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. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.

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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

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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 developmen

• t.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 product
• s.Drafts engineering technical reports, test method work instructions or procedures and test method validation related document
• s.Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validati
• onAuthors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality System (QS) and regulatory requiremen
• tsManages and tracks product configurations through design verification and validati
• onPerforms hands-on and simulated testing for design verification and test method developmen
• tsConducts functional and performance testing of products to ensure that the product and its components meet the required specificatio
• nsInteracts with external development partners and equipment suppliers, Operations, Quality, and IT/Infrastructure groups to achieve design verification and validation deliverabl
• esSupports 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 (RC
• A)Oversight of test methods and ensuring equipment is validated per business requirement

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Education & Experien

• ce Minimum of Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering or related fi
• eld8+ years of professional experience in the medical device, pharmaceutical or life sciences fie
• ld.Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), et
• c.)Experience with executing Design Verification and/or Design Validation on a mechanical or electromechanical medical dev
• iceDemonstrable 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 packa
• gesPractical experience with implementing product changes through a structured, phase-gated product development process within a regulated framew
• orkExperience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential soluti
• onsWorking knowledge of applicable medical device regulatory standa