Manufacturing Validation Engineer
Created by firstname.lastname@example.org on 5/27/2022 10:10:35 AM
Job Title: Manufacturing Validation Engineer
Reports to: Head of Engineering and Quality
Start Date: June 2022
Hours of Work: 37.5 hours per week (full-time, 6-month probation)
Salary: £38-45k PA
Please send your CV and a cover letter explaining what you can bring to MediSieve to email@example.com.
Imagine a world where doctors are able to target and remove infected cells, pathogens, toxins, or even viruses directly from a patient’s bloodstream. At MediSieve we are working towards bringing this dream into a reality. Our Magnetic Blood Filtration System is a device-therapeutic combination that filters harmful substances from the bloodstream using magnetic forces.
If you’ve always dreamt of making a global impact, MediSieve is the place to be! The platform nature of our technology enables us to make a difference in treating humanity's most serious diseases, with the first product targeting hyperinflammation in conditions such as COVID-19, Sepsis, and Cytokine Release Syndrome. And you have the opportunity to join our diverse, energetic, and fun team at the most exciting time – just before our clinical trials begin!
As Manufacturing Validation Engineer you will fulfil a key role in the delivery of a new Medical Device to the market. This will include elements of Verification & Validation testing; leading packaging validation via new 3rd party suppliers; maintaining relationship and co-ordination of current 3rd party suppliers; engaging with test houses to produce protocols and ensure these are reported accurately. As well as early stage development you will also be responsible for developing protocols and running shelf-life, shipping, and transport studies. This will culminate in a role that has a deep understanding of the device and will work closely with the Quality Department to maintain product standards via goods in and supplier management.
What You’ll Be Responsible for
- Leading pre-CE submission process validation requirements
- Working alongside our manufacturers to ensure they meet our validation requirements
- Guide R&D design work to enable successful validation
- Supplier management and validation maintenance
What We Look for in a Candidate
- Communication with critical suppliers and external companies
- Knowledge of standards including ISO13485, ISO14971, ISO11607, ASTM F1980, ASTM D4169
- Working within a highly regulated industry
- Relevant degree
- Worked under an ISO13485 certified QMS
- Shelf life, packaging and shipping transport study experience
Not Essential, but Helpful
- Verification and validation planning
- Experience of extracorporeal systems
- People management.
- eQMS/PLM experience
- Validation maintenance
- Risk management experience
You’ll Love This Job if You Are:
- A problem solver
- Enthusiastic about our mission
- Attentive to detail
- Team-oriented, fun and have excellent interpersonal skills
- Remote work
- 3% Company pension
- 25 days holiday
- Share options scheme
- A vibrant community of Imperial College’s Translation & Innovation Hub
Diversity Commitment: We believe that diversity enables us to see situations from different points of view, leading to ideas and insights which would otherwise be missed. We are focused on building an inclusive team of people of all backgrounds, experiences, abilities, and perspectives. We are diverse in gender (58% women), origin (6 nationalities) and economic background. Everyone is welcome — there will be no judgement towards things that make you You!
Learn more at https://www.medisieve.com