R&D Project Manager – 12 month FTC
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Job Details
To deliver R&D projects in Company business plan ensuring compliance with medical device/FDA procedures. To support Sales & Marketing, Operations, Quality and Regulatory Affairs with the commercialisation, manufacture and maintenance of products.
What will this role involve?
* Planning, controlling and monitoring technically complex product development projects
* Project-related leadership of cross-location teams to achieve the project goals.
* Participation in the evaluation of the project proposal, the development of the project mandate and the identification of stakeholders including the co-ordination of resource allocation with line managers and clients and be responsible for communication management.
* To follow the company’s Product Development Process and present at key decision points to business unit management team and Project Review Board.
* To oversee Design Control activities, including ensuring appropriate document approval.
* To oversee the Risk Management process for new product development projects, ensuring compliance to ISO 14971.
* Keep all stakeholders informed of progress and issues. Reporting project status via the New Product Development Process (NPD process).
* Active management of project risks and conflicts.
* To form strong relationships and coordinate activities with internal and external customers, including external business partners, vendors, contractors and test houses.
* To apply comprehensive and skilled knowledge of engineering/ scientific principles to the design, development and manufacture of medical devices.
* The jobholder is responsible to follow company and quality procedures and maintain training records, including ensuring compliance with relevant GMP, GLP, Health & Safety standards.
* To perform all reasonable tasks requested of them by their manager
What we're looking for?
* A general knowledge and understanding of projects work and adherence to deadlines.
* Knowledge and understanding of product development procedures and processes.
* Knowledge of GMP/ISO13485/EN4600/FDA quality systems.
* Thorough understanding of test procedures.
* Good communication skills and organisational skills.
* Educated to A-level in a science of engineering discipline as a minimum.
* Attention to detail and analytically minded.
* Familiarity with PC Systems and appropriate software.
* Ability to analyse test results, compare against acceptance criteria and present a report.