Deskripsi Pekerjaan
Are you a dedicated engineering professional seeking a challenging role in the healthcare sector? We are looking for a qualified Medical Device Engineer to join our team in the West Region. In this key position, you will be responsible for ensuring that our innovative medical products adhere to strict regulatory frameworks, specifically ISO 13485 and FDA 21 CFR Part 820 (QSR).
Your expertise in Project Management will be critical as you oversee the development lifecycle, ensuring that all engineering deliverables meet safety and quality standards. You will collaborate closely with cross-functional teams to drive product excellence and compliance. If you have a passion for quality assurance and a desire to contribute to life-saving technologies, this is the opportunity for you.
Tanggung Jawab
- Ensure full compliance with ISO 13485 and FDA 21 CFR Part 820 quality management systems.
- Lead and manage engineering projects from design inception to final product launch.
- Conduct thorough risk assessments and perform validation testing on medical devices.
- Prepare and maintain comprehensive technical documentation, including DFMEA and control plans.
- Collaborate with R&D, Quality Assurance, and manufacturing teams to resolve technical issues.
- Investigate root causes of non-conformance and implement corrective actions.
- Stay updated on regulatory changes and industry best practices.
Kualifikasi
- Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering.
- Proven experience with ISO 13485 and FDA 21 CFR Part 820 regulations.
- Strong background in Project Management within the medical device industry.
- Proficiency in engineering analysis tools and CAD software.
- Excellent communication skills for technical reporting and stakeholder management.
- Ability to work effectively in a fast-paced, regulated environment.
- Relevant professional certifications (e.g., RAC, CQE) are highly desirable.