Device Performance Engineer
4 days ago
We are partnering with a leading healthcare company to find two Principal Scientists for their Device and Product Performance team.
This opportunity enables you to make a significant impact on the development of Combination Products. You will lead the design and execution of testing strategies, collaborating with multi-disciplinary teams to ensure product performance and compliance with industry standards.
The ideal candidate will have:- A strong background in Science or Engineering
- Over 7 years of experience in drug delivery systems and/or medical devices
- 3-5 years of hands-on experience with Combination Product Performance
- A solid understanding of design control practices, including medical industry standards
- Strong expertise in developing and validating analytical testing methodologies
- Proficiency in applying statistical methods for data analysis
- Experience in preparing regulatory submissions and ensuring compliance with industry standards
- Proven experience as a Subject Matter Expert, delivering presentations to both technical and non-technical audiences
- Offer subject matter expertise to drive the development of Combination Products
- Lead a team to design and execute strategies for design verification and reliability testing
- Act as the key technical liaison between drug product and device teams throughout combination product development
- Create design requirements and specifications based on regulatory standards, user requirements, and comparison with competitor products
- Design and implement test methods to evaluate device performance
- Conduct material evaluations, biological assessments, and extractables testing for components
- Provide technical guidance during the development of manufacturing and assembly processes
- Leverage statistical analysis to support design decisions and test method validations
- A collaborative and dynamic work environment
- Ongoing professional development and training opportunities
- An opportunity to work with a global leader in the healthcare industry
- A competitive salary and benefits package
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