Job Overview
This organization is seeking a skilled Product Introduction Engineer to join their team. The ideal candidate will have experience in supporting operations teams during the pilot production and commercial launch phases.
Main Responsibilities:
* The successful candidate will be responsible for executing equipment, process, and test method validations to ensure seamless product introduction.
* They will support the manufacturing process, identifying potential risks and implementing mitigations to improve yields and efficiency.
* Responsibilities will also include tracking and executing New Product Introduction activities ahead of commercialization.
* Collaboration with equipment vendors to identify areas for process improvement will be key to this role.
* The engineer will create a strong culture of problem-solving using standard tools like DMAIC and 6 Sigma.
* A well-structured process development plan will be developed to ensure budget, risk, and timeline focus.
* Closely working with the R&D team will be essential to facilitate their programs within production plans.
* Materials, process, and equipment improvement projects will also be worked on in collaboration with R&D.
* A master validation plan for line equipment will be created and updated by the engineer.
* Maintenance and calibration of all line equipment will be ensured by the responsible individual.
* Execution of IQ/OQs for lab and production equipment will also be handled.
* Project activities will be communicated and updated using project management methodologies.
Requirements & Qualifications:
* A Bachelor's degree in Mechanical Engineering, Manufacturing, Chemical Engineering, Biomedical Engineering, or a relevant engineering discipline is required.
* At least 2 years of work experience in a manufacturing or process development-related role in a medical device company is necessary.
* Experience with new equipment introduction (IQ/OQ) and process characterization and validation is expected.
* Process characterization and process validation, including test method validation experience, is also required.
* Familiarity with processes like Lyophilisation is desirable.
* Demonstrated experience with GDP & GMP standards is essential.
* An excellent knowledge of engineering materials used in medical device manufacture, such as hydrogels, metals, and polymers, is needed.
* A strong problem-solver with knowledge and experience of DMAIC or other problem-solving tools is expected.
* Must be organized, demonstrate innovation, and possess a strong work ethic on individual projects and as part of a project team.
* Effective communication skills - both verbal and written - in English are necessary.
* Comfortable with hands-on and technical work is a must.
What We Offer:
We offer an exciting opportunity for the right candidate to grow professionally while contributing to the success of our organization. If you're passionate about product introduction engineering and have the necessary skills, we look forward to receiving your application!