Medical Device Verification Specialist

6 days ago


Dublin, Dublin City, Ireland Embecta Full time
Job Description

As a Senior Validation Engineer, you will play a crucial role in ensuring the quality and safety of medical devices. Your primary responsibility will be to develop and execute design verification and validation plans for new and existing products.

About Us

Embecta is a global diabetes care company with a 100-year legacy in insulin delivery. We are dedicated to empowering people with diabetes to live their best life through innovative solutions, partnerships, and a passionate team of over 2,000 employees worldwide.

Key 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

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

- Competitive pay
- Benefits program
- Continuous learning opportunities
- Recognition and career growth opportunities
- Life balance components

Our Total Rewards Program

We offer a comprehensive benefits package designed to support the varying needs of our diverse and global employees.

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