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Senior Design Assurance Engineer
Sandoz
- Cambridge, England, United Kingdom
- Cambridge, England, United Kingdom
Über
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves both professionally and personally.
Join us – the future is ours to shape!
Responsibilities
Provide expertise in a range of design assurance skills including risk management; HF/UE activities verification and validation internal auditing.
Act as senior DA Engineer within programs providing strategic and technical oversight pertaining to DA Engineering.
Provide support and development for junior colleagues within the project or standalone mentorship.
Provide support to the group leader as required to aid with the smooth running of the department.
Lead initiatives to improve the efficiency and effectiveness of the group.
Lead or participate in design reviews.
Specific program responsibilities e.g. risk management team leader design history file owner etc.
Qualifications
Masters, PhD or university degree in engineering, quality life sciences or other relevant subject.
Proven track record in development of medical devices (ideally in drug delivery) and/or combination products within a pharmaceutical medical devices setting.
Extensive technical knowledge of medical device technology and drug-device combination products.
Proven ability to provide guidance and mentorship to junior engineers.
High level of proficiency in multiple engineering areas: risk analysis (in line with ISO 14971); HF/UE specification setting; Good Documentation Practice etc.
Results oriented, enthusiastic and driven by excellence.
Excellent command of English (verbal and written).
Experience working within the ISO 13485 medical devices quality framework and in-depth knowledge of GMP EU and FDA regulatory requirements.
Benefits
Competitive salary.
Annual bonus.
Pension scheme.
Health insurance.
24 days annual leave.
Flexible working arrangements.
Employee recognition scheme.
Learning and development opportunities.
Commitment to Diversity & Inclusion We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
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Sprachkenntnisse
- English
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