Product Development Engineer

Job Profile Summary:

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 combinationproduct technologies.

Immediate contributions can be made by a candidate with the following experience:

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

Key Duties and Responsibilities:

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.

1. Must have experience with qualification and validation of container closure systems for pharmaceutical products ensuring compliance with regulatory requirements (e.g. FDA EMA).
2. 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.
3. Must have developed and optimized container closure integrity testing methods to detect leaks and defects in container closures.
4. Experienced in automated testing systems and equipment (e.g. high voltage leak detection laserbased headspace analysis) to improve testing efficiency and sensitivity.
5. Must conduct risk assessments to identify potential sources of container closure integrity failures and implement mitigation strategies to reduce risks.
6. Must have experience in design controls and DVt experience in container systems and packaging of combination devices.
7. Experienced in Sterilization techniques for container closure and med device packaging systems.

Knowledge and Skills:

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

Education and Experience:

Bachelors degree in Mechanical Engineering Biomedical Engineering or related field is required.

Typically requires a Bachelors degree with at least 5 years of experience or a Masters degree and at least 3 years of experience or the equivalent combination of education and experience

Mandatory Skills:

Integrity testing

Method Validation

Method testing