Job Title: Senior Validation Engineer
We are seeking a highly skilled and experienced Senior Validation Engineer to join our team. The ideal candidate will have a strong background in mechanical engineering, biomedical engineering, electrical engineering, or systems engineering, with a minimum of 8 years of professional experience in the medical device, pharmaceutical, or life sciences field.
* 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.
* 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.
Requirements:
* 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.
* Working knowledge of applicable medical device regulatory standards.
Benefits:
Our company offers a competitive salary, benefits package, continuous learning opportunities, recognition, career growth, and life balance components to support the varying needs of our diverse and global employees.
Additional Information:
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.