Negotiable
Undetermined
Undetermined
Winsford, England, United Kingdom
Summary: The R&D Project Manager will oversee the planning, execution, and monitoring of complex product development projects within Advanced Medical Solutions, ensuring compliance with medical device and FDA procedures. This role involves leading cross-location teams, managing project risks, and maintaining communication with stakeholders throughout the project lifecycle. The position requires a strong understanding of product development processes and adherence to quality standards in the medical device industry. The successful candidate will contribute to the commercialization and maintenance of innovative tissue-healing technologies.
Key Responsibilities:
- Planning, controlling, and monitoring technically complex product development projects.
- Leading cross-location teams to achieve project goals.
- Evaluating project proposals and developing project mandates.
- Coordinating resource allocation with line managers and clients.
- Following the company’s Product Development Process and presenting at key decision points.
- Overseeing Design Control activities and ensuring document approval.
- Managing the Risk Management process for new product development projects.
- Keeping stakeholders informed of progress and issues.
- Reporting project status via the New Product Development Process.
- Managing project risks and conflicts actively.
- Forming strong relationships with internal and external customers.
- Applying engineering/scientific principles to the design and development of medical devices.
- Following company and quality procedures and maintaining training records.
- Performing all reasonable tasks requested by the manager.
Key Skills:
- General knowledge of project work and adherence to deadlines.
- Understanding of product development procedures and processes.
- Knowledge of GMP/ISO13485/EN4600/FDA quality systems.
- Thorough understanding of test procedures.
- Good communication and organizational skills.
- Educated to A-level in a science or engineering discipline as a minimum.
- Attention to detail and analytical mindset.
- Familiarity with PC systems and appropriate software.
- Ability to analyze test results and present reports.
- Experience in project management, preferably in medical devices.
Salary (Rate): undetermined
City: Winsford
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 or 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.
- Experience in project management.
- Project Management in medical devices preferred.