As a member of the Electronic & Commercial Devices team within the Devices, Packaging & Wearable Technologies department, this role supports Quality Engineers in ensuring technical quality and life cycle management of drug delivery technologies and other medical devices for chemical and biological medicines. The responsibilities include participating in cross-functional technical program teams, contributing to design, development, industrialization, and life cycle management of medical device programs. The role reports to the Electronic & Commercial Devices Head.
Major Accountabilities:
- Perform technical activities for on-market and life cycle management of medical devices.
- Contribute to technical medical device activities related to market feedback, life cycle management, and documentation.
- Project planning, tracking, and addressing program challenges within program teams.
- Ensure compliance with combination product and medical device quality management systems, collaborating with quality assurance and medical device vendor management teams.
Education & Qualification:
- Bachelor's Degree (Minimum)
- Project management, medical device development, industrialization, production, quality experience
- Pharmaceutical business experience
- Familiarity with regulatory standards (ISO 13485, 21 CFR820, Medical Device Directive)
- Project management skills
- Experience in evaluating external projects and technologies
- Knowledge of health, safety, and environmental processes and procedures
Competencies:
- 3-5 years of experience in the pharmaceutical/biologics/medical device industry.
- Understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
- Green Belt and/or Project Management certification is advantageous.
Competency Highlights:
- Delivering Solutions: Analyzing and evaluating technical information in portfolio.
- Decision Making: Proposing and contributing to decisions on medical device programs.
- Communications: Effectively communicating complex technical data internally and externally.
- Accountability & Financial Management: Ensuring technical activities align with regulatory and quality systems requirements.
