- The Product Development Engineer will be responsible for offering a high level of technical contribution to product development and optimization for ongoing and future projects. This role will contribute to the commercialization of novel combination-product technologies.
- Knowledge in packaging of medical devices, packaging and shipping combination product in "cold" conditions
- Different methods of producing sterile medical products such as terminal sterilization and aseptic processing techniques
- Thorough knowledge of the Design Control process (e.g. waterfall model)
- Capturing user needs and design inputs and understanding/ability to execute corresponding Design verification and validation activities (e.g. feasibility testing, protocol development, and technical report writing)
- Working in controlled environments (e.g. Laboratory, cleanrooms, biosafety cabinets, etc.)
- Working in a GxP environment
- Working under FDA 21CFR part 820 regulations
- Effectively collaborates with a fully integrated team to facilitate the success of projects
- Applies fundamental scientific and engineering principles to process design, development, and process understanding.
- Applies statistical principles to guide process optimization
- Strong technical writing, authoring and reviewing protocols and reports.
- Interacting regularly with outside vendors, and work effectively with cross functional teams within the same site, and across multiple sites.
- Must have experience with qualification and validation of container closure systems for pharmaceutical products, ensuring compliance with regulatory requirements (e.g., FDA, EMA).
- Should be experienced in developing and executing protocols for container closure integrity testing (CCIT) using various methods such as dye ingress, microbial ingress, and vacuum decay.
- Must have developed and optimized container closure integrity testing methods to detect leaks and defects in container closures.
- Experienced in automated testing systems and equipment (e.g., high voltage leak detection, laser-based headspace analysis) to improve testing efficiency and sensitivity.
- Must conduct risk assessments to identify potential sources of container closure integrity failures and implement mitigation strategies to reduce risks.
- Must have experience in design controls and DVt experience in container systems and packaging of combination devices.
- Experienced in Sterilization techniques for container closure and med device packaging systems.
- Excellent communication skills to explain complex technical/scientific information to others
- Ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field is required.
- Typically requires a Bachelor's degree with at least 5 years of experience or a Master's degree and at least 3 years of experience, or the equivalent combination of education and experience
- Integrity testing
- Method Validation
- Method testing
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Product Development Engineer
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Product Development Engineer - Providence, United States - Fusion Life Sciences Technologies LLC
Description
Job Profile Summary:
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