Product Design Engineer Role
Our organization seeks a seasoned Product Design Engineer to spearhead the development of innovative combination products. This key position plays a pivotal role in shaping the design and functionality of prefilled pens, syringes, auto-injectors, and medical devices.
Key Responsibilities:
1. Support device development programs throughout the entire product lifecycle, ensuring seamless integration with quality management systems and regulatory requirements.
2. Establish and maintain detailed records for Design History Files, guaranteeing compliance with industry standards.
3. Collaborate effectively with internal stakeholders, partners, and third-party vendors to ensure robust controls and evidence are established and upheld.
4. Integrate acquired combination products and medical devices into our portfolio, assessing and ensuring compliance with relevant regulations and design control requirements.
Required Skills and Qualifications:
* Education: Degree or Master's in engineering or a life science discipline.
* Industry experience: Medical Device or Pharmaceutical sector (with emphasis on devices).
* A minimum of 5-7 years of experience at a similar level or 5-10 years of general experience in the industry.
* Demonstrated expertise in device development, manufacturing operations, and GMP environments.
* Proven track record in implementing design controls and adhering to ISO/FDA requirements.
Benefits of this Role:
This esteemed position offers an exciting opportunity to make a lasting impact in the field of product design engineering. As a member of our team, you will enjoy a dynamic work environment, opportunities for growth and professional development, and the satisfaction of contributing to the creation of cutting-edge medical solutions.