Project Manager

Planning, management and execution of medical device development projects to realise the handheld electrosurgical instrument portfolio

• Liaise with all project stakeholders and sponsors to develop comprehensive project plans so that required resources and schedules to realise project output are identified
• Execution of project in compliance with prescribed project management methodology to defined cost, quality and time in order to realise product development objectives
• Identify and manage project risks, issues and opportunities to ensure that the project maintains compliance to the agreed quality, cost and duration targets
• In the absence of a project Technical Authority, provide the technical input, review and approval for all project output to ensure compliance with agreed specifications and all relevant regulatory standards
• Research and maintain a strong and current understanding of relevant new product development, Project Management principles, materials and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
• Generate and review design history file documentation in compliance with Good Manufacturing Practice (GMP), Quality System Regulations (QSR), International Standards Organisation (ISO) and company Product Development Process (PDP) requirements throughout the project life cycle to ensure the design is fully documented.
• Present clear, concise written and verbal communication to keep customers, stakeholders, senior management and project team members informed of progress, risks, issues and opportunities to ensure project deliverables are achieved
• Manage and develop a team of engineers to ensure their output is accurate and timely in line with industry standards and regulatory requirements
• Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook
• All other essential related duties as required.

Supervision of up to three roles including:

• Senior Product Development Engineers
• Product Development Engineers
• Process Development Engineers

Management of individual project budgets as agreed in NPP (typically up to £5 million)

Education / Qualifications:

• Bachelor’s degree in an appropriate Engineering discipline or equivalent with a minimum of 5 years\’ experience in a regulated and highly mechanical engineering design environment with Project Management experience

Behaviours / Skills / Experience:

• Ideally medical device design or development experience
• Good analytical skills
• Ability to manage multiple projects and budgets
• Ability to effectively and efficiently plan and coordinate multiple tasks/projects.
• Ability to use initiative
• Strong problem solving skills
• Excellent verbal and written communication skills
• Ability to lead, motivate and develop team members to achieve results.
• Ideally cGMP, ISO 13485, & FDA QSR knowledge as practiced in the disposable medical device industry

Competent in MS Word, PowerPoint, Excel and Project

What you should know about us:

ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site (GML Medical Ltd – an ATL Technology owned Company) is based in St Mellon\’s, Cardiff, UK.

We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one\’s life\’. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.

ATL has operations in the UK, China, Costa Rica, Taiwan, Utah & Minnesota, USA, plus remote staff in strategic global locations and we\’re growing!

Other information

You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006. The role that you are applying for may require you to undertake a basic/standard/enhanced Disclosure & Barring Service (DBS) check.

At Gyrus Medical Ltd (An ATL Technology Company), we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Gyrus or ATL will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions. Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Gyrus Medical Ltd from your mailing list. Thank you for your understanding.

Gyrus Medical Ltd (an ATL Technology Company) is an equal opportunity employer.