Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Provide expertise in a range of design assurance skills including: Risk management; HF/UE activities, verification and validation, and 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, either 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.
What you’ll bring to the role:
Essential Requirements:
Masters, PhD, or university degree in the field of engineering, Quality, life sciences, or other relevant subject
Proven track record in the development of medical devices (ideally in the field of drug delivery) and /or combination products within a pharmaceutical, medical devices, and/or combination products 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-orientated, enthusiastic, and driven by excellence
Excellent command of English (verbal and written)
Experience working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements
You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
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.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
#Sandoz
Skills Desired
Cad Software, Circuit Design, Design Engineering, Design for Manufacturability (DFM), Fea (Finite Element Analysis), Mechanical Design, Mechanical Engineering, Npd (New Product Development), Product Design, Systems Design, User Research