Project Manager

Job Description

As Project Manager, the role will be primarily focused upon new product development which is where you will have gained your prior experience. However, this dynamic and proactive role also provides a breadth of wider project management opportunities includingbusiness process improvements, research projects and support of new business opportunities.Client DetailsPageGroup Scotland are delighted to be supporting emblation - an award-winning medical technology company, revolutionising the way microwave energy is used in healthcare.Their aim is to improve on traditional treatments, using the unique advantages microwaves deliver - accurate, repeatable procedures, and better clinical outcomes.Their technology is revolutionising the treatment of HPV infections globally, and is widely used in Dermatology, Podiatry and Oncology, with a number of disruptive applications under development in the fields of Cardiology and Gynaecology.The company was started in 2007 by joint co-founders and inventors behind the technology. They form part of the highly experienced management team with over 50 years of experience in this field.You can now find emblations medical devices across the UK, the US, Canada, and Australia.Having recently secured additional investment into the business to fund the next stages of the companys development, underpinned by 3 primary goals:* Expansion into new treatment areas* Development of new markets and a wider global presence* The addition of new talent to our Scottish Headquarters to bring the skills andexperience needed to support our plans for growthDescriptionThe Project Manager role is perfect for an innovative, hands-on self-starter who would like to work as part of a driven and supportive team which designs and manufactures novel medical device products to improve the world around us!As Project Manager the role will be primarily focussed upon new product development which is where you will have gained your prior experience to complement your Engineering qualifications. However, this dynamic and proactive role also provides a breadth ofwider project management opportunities including business process improvements, research projects and support of new business opportunities.The role would ideally suit a Project Manager who enjoys working across the full product lifecycle - from product concept through to manufacturing support - and who has experience in project managing product development of electronics products. The rolewill include responsibility in project managing an innovative new medical treatment platform, incorporating planning, specification, design, verification, validation, transfer to manufacture and market release.As a medical devices company, certified to ISO 13485, accuracy of documentation is essential throughout the organisation. The ideal candidate will have acute attention to detail, with a rigorous and methodical approach to defining task requirements and ensuringdeliverables are comprehensively met.Project Management and Quality AssuranceProject management of the development and certification of medical device systems and products incorporating advanced microwave technology, including all verification and validation activities in accordance with the Companys design control procedures andin compliance with ISO13485 and QSR.Management of internal and external resources including suppliers, subcontractors, other engineering disciplines, quality, regulatory and manufacturing.Maintaining effective communication with senior management, customers and the project team through oral and written correspondence, project status reports, and monthly progress reports, and ensuring adequate documentation of each communication.Product DevelopmentDeveloping and qualifying new products in accordance with the Companys design control procedures and quality standards.Managing verification and validation activities to agreed schedules, quality and cost.Providing technical and managerial support for using prototype and pre-production systems in preclinical and clinical trials.Generating design documentation in compliance with the Companys design control procedures.Developing and assisting in the feasibility of new concepts in alignment with the requirements of the Companys Research strategy.ProductionSupporting Operations through management of product Transfer To Manufacturing; project handover.Managing and generating manufacturing documentation in compliance with quality standards.Supporting the implementation of best practice manufacturing techniques for one-off designs to high volume production, assembly processes and material selection.Profile* Previous experience of working in a system level/electronics PM role, ideally within a highly regulated industry sector such as medical (preferred), aerospace or defence.* Bachelors degree in an Engineering/Electronics related subject.* Formally Project Management trained, such as Prince 2 Practitioner or PMP qualified* Fully proficient with MS Project.* Proven track record in an engineering product environment, with an understanding of Engineering Principles and Design Practices.* Experience of working within the Medical Devices (preferred), pharmaceuticals or life sciences sectors is highly desirable, as is a strong understanding of regulatory requirements, particularly ISO 13485, IEC 62304 and IEC 60601.* Strong customer facing skills, and able to handle any size group meetings.* The role would suit a motivated self-starter, with a demonstrated ability to create ideas and develop solutions.* Driving license and ability for infrequent travel, primarily to local CEM partner.Job OfferExcellent Salary, BenefitsOpportunity to be part of a business with rapid expansion across the Globe.Progression and Development opportunities with excellent career opportunities.Remote Working 2 Days per week

Keyskills :
Medical DevicesProject ManagerPharmaceuticalsISO 13485Prince 2 PractitionerLife SciencesEngineering/ElectronicsPMP qualifiedIEC 62304 and IEC 60601