- Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products.
- Provides inputs on design input requirements to ensure that they are unambiguous, non-conflicting and testable and crafts rationales or justifications to support applicability of the requirements to the design project.
- Assists with planning for test method validations (TMV) and drafts TMV protocols, utilizing relevant statistical principles like Gage R&R, ANOVA analysis, etc.
- 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, including Hardware/Software/Firmware version tracking, to allow for determination of impact due to configuration changes.
- 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.
- Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents.
- 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).
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering or related field
- 5+ years of professional experience in the medical device, pharmaceutical or life sciences field.
- Applied experience in developing and qualifying electromechanical test systems or test 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.
- Practical experience with implementing product changes through a structured, phase-gated product development process within a regulated framework.
- 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.
- 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 i.e.: FDA 21CFR 820, ISO 13485, ISO 11607, IEC 60601, ISO 10993, ISO 14971, etc.
- Graduate degree (MS or PhD) in Engineering or related field
- 8+ years of post-educational experience in Medical Device Design highly desired
- Six Sigma certification training / experience
- Prior experience with executing mechanical safety testing per IEC , IEC and related collateral standards, working with external test houses.
- Drug delivery or combination medical device development experience highly desired.
- Proficiency with advanced statistical techniques; including Reliability Testing & Analysis, Analysis of Variance (ANOVA) and Design of Experiment (DOE).
- Expertise in common risk management techniques, e.g.: FTA, FMEA, Hazard Analysis, etc.
- Leadership and team building skills.
- Disciplined and well organized.
- Ability to manage competing simultaneous priorities effectively.
- Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally.
- Demonstrated deep understanding of establishing project and product requirements.
- Highly collaborative both within the function and with other functions.
- Advanced technical and managerial judgment; advanced problem-solving skills.
- Self-initiator, results driven and action & detail oriented.
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Senior Engineer, R&D - Andover, United States - embecta
Description
embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels on LinkedIn, Facebook, Instagram and Twitter.
The Senior Engineer, R&D - Verification and Validation, is accountable for the planning and execution of design verification or design validation testing in support of new product development as well as sustaining design projects, for complex electromechanical medical devices. Reporting up to the Associate Director, R&D - Verification and Validation, the successful candidate brings prior electromechanical medical device R&D or design quality assurance experience, to facilitate successful regulatory submissions of candidate product designs, in the US as well as other geographical regions.
Responsibilities include but not limited to the following:
