Mark Knowles

Mark Knowles Email and Phone Number

Head of Device Development @ invoX Belgium (formerly Softhale NV)
Wymondham, GB
Mark Knowles's Location
Wymondham, England, United Kingdom, United Kingdom
Mark Knowles's Contact Details

Mark Knowles personal email

About Mark Knowles

** I have…Over 30 years experience in Research & Development (R&D) Programme (PMO), Project and Engineering management. I have managed complex, safety critical projects for new product development (NPD), owned and continuously improved the underlying innovation process and built successful teams of project managers and engineers.** I am…Lean Six Sigma Black Belt trained (Smallpeice), a chartered engineer and I have an MBA in technology management. A highly driven, personable individual with excellent communication and networking skills. Key personal strengths in trouble shooting and problem solving. I bring clarity to complex issues and guide teams to a common understanding and approach to solve them.** I can offer…=> R&D people, process, programme and portfolio (PMO) management for new product development, (speciciality: medical devices)=> Systems engineering applied to 13485 medical device development; hardware & software engineering management ISO12207=> Technology management ; full understanding of project lifecycle processes , concept development tools (QFD, AHP), design, verification & validation and design transfer into manufacturing=> R&D business and operational programme management; product roadmapping, deployment and delivery=> People development; personal development, coaching & mentoring=> Quality engineering; detailed knowledge/developed standard working procedures for ISO13485, 21 CFR 820.30, ISO14971=> Change management; continuous improvement using LEAN techniques (policy deployment planning, root cause 8D analysis, A3’s)=> Outsourcing management; contract creation, review and control=> IT skills; Minitab, MS Office, MS Project, Excel (vbscript), SharePoint

Mark Knowles's Current Company Details
invoX Belgium (formerly Softhale NV)

Invox Belgium (Formerly Softhale Nv)

View
Head of Device Development
Wymondham, GB
Website:
invoxpharma.com
Employees:
70
Mark Knowles Work Experience Details
  • Invox Belgium (Formerly Softhale Nv)
    Head Of Device Development
    Invox Belgium (Formerly Softhale Nv)
    Wymondham, Gb
  • Invox Belgium (Formerly Softhale Nv)
    Head Of Device Development
    Invox Belgium (Formerly Softhale Nv) Jun 2024 - Present
    Diepenbeek, Limburg, Be
    Design and development of soft mist inhalers
  • Bespak
    Head Of Product Engineering
    Bespak Sep 2015 - Apr 2024
    Holmes Chapel, England, Gb
    Engineering management (+40 mechanical engineers) of research, development, new product introduction (NPI) and product support of proprietary (pMDI, nasal, dose counters, medical check valves, auto injectors) and non-proprietary contract manufacturing of therapeutic, diagnostic and drug delivery medical devices (respiratory & parenteral). Product engineering and design transfer into high volume manufacturing (GMP). Key highlights;=>Drove development of a key product doubling output over 5 years=>Grew a team from ~20 to ~40 engineers implementing Design for Six Sigma tailored training tools (smallpeice enterprises) - drove the development of key nasal product using these robust design methdologies=>Instantiated a key KTP research activity for modelling and simulation of drug delivery devices=>Forged relationships with key Univerisities and outsourcers increasing research and development output=>Supported team career development towards chartership of iMechE
  • Bespak
    Principal Programme Manager
    Bespak Aug 2014 - Aug 2015
    Holmes Chapel, England, Gb
    Management of a fluidics PCR IVD device for a client; new product introduction (NPI) and design transfer into manufacturing (GMP).
  • Medeli Ltd
    Interim R&D Programme/Project Manager
    Medeli Ltd May 2013 - Jul 2014
    Freelance programme & project work, utilising over 20 years experience in R&D/medical device project management.
  • Cambridge Consultants
    Associate Director Programme Management
    Cambridge Consultants Sep 2011 - Apr 2013
    Cambridge, Cambridgeshire, Gb
    Management of client based large medical device programmes; IVD, surgical and drug device related.
  • Elekta
    Project Office Manager (Pmo)
    Elekta Aug 2005 - Aug 2011
    Stockholm, Se
    Led a team of project managers to deliver complex medical device products; safe, effective and on time.Improved the efficiency of delivery using LEAN process techniques applied to New Product Development.Met the needs of the sales driven origanisation with the money and resources available.
  • Elekta
    Project Manager (Contract)
    Elekta May 2001 - Aug 2005
    Stockholm, Se
    High precision collimator development and transfer into full productionImage guided cone beam CT new product development for use with linear accelerators. Rollout to new market and follow up general release
  • Thales
    Database Consultant (Contract)
    Thales Sep 2000 - May 2001
    Meudon, Île-De-France, Fr
    Large database image storage. Design and tuning for high speed access
  • Elekta
    Engineering Leader (Contract)
    Elekta Sep 1996 - Sep 2000
    Stockholm, Se
    Next generation control system and GUI for digital linear accelerator; development of the Patient Database and ODBC interfaces to softwareManagement of key project deliverables
  • Reuters Financial Software
    Software Engineer (Contract)
    Reuters Financial Software Sep 1995 - Sep 1996
    Fr
    Back office trading software development using C
  • Bnp Paribas
    Software Engineering Leader (Contract)
    Bnp Paribas Sep 1994 - Sep 1995
    Paris, Fr
    Back office trading software feeds development using C and SQL
  • Admiral
    Software Engineer
    Admiral May 1993 - Sep 1994
    Luton, Gb
    Developing financial reports for the Financial Times using C-libraries
  • Eurotherm
    Software Engineer
    Eurotherm Sep 1989 - May 1993
    Worthing, West Sussex, Gb
    Development of SCADA logging model using GML, C & SQLAutomation of a freeze dryer unit for Genzyme using client/server based GML tools & SQL databaseAutomation of plastic pipe extrusion line and interface to the MIS for Stewarts & Lloyds PlasticsAutomation of hot metal extrusion line for Inco Alloys
  • Philips
    Graduate Engineer
    Philips Jul 1988 - Sep 1989
    Amsterdam, Noord-Holland, Nl
    Advanced development prototyping of EW radar systemsDevelopment of transputer based MMI using Occam

Mark Knowles Skills

Program Management Product Development Medical Devices R&d Management Project Management Software Project Management Change Management Cross Functional Team Leadership Manufacturing Iso 13485 Engineering Process Engineering Leadership Continuous Improvement Lean Manufacturing Validation Quality Assurance Project Planning Strategy Software Engineering Pmo Sharepoint Project Portfolio Management Product Launch Process Improvement Systems Engineering Business Process Improvement Quality System Testing Fmea Process Development Portfolio Management Team Leadership Strategic Planning Team Building Quality Management Software Development Problem Solving Product Design Contract Management Product Management Six Sigma Fda Risk Management Business Strategy Strategy Development People Management Coaching Mentoring

Mark Knowles Education Details

  • The Open University
    The Open University
    Technology Management
  • University Of Brighton
    University Of Brighton
    B.Eng

Frequently Asked Questions about Mark Knowles

What company does Mark Knowles work for?

Mark Knowles works for Invox Belgium (Formerly Softhale Nv)

What is Mark Knowles's role at the current company?

Mark Knowles's current role is Head of Device Development.

What is Mark Knowles's email address?

Mark Knowles's email address is mw****@****ail.com

What schools did Mark Knowles attend?

Mark Knowles attended The Open University, University Of Brighton.

What are some of Mark Knowles's interests?

Mark Knowles has interest in Children, Civil Rights And Social Action, Poverty Alleviation, Disaster And Humanitarian Relief, Human Rights, Health.

What skills is Mark Knowles known for?

Mark Knowles has skills like Program Management, Product Development, Medical Devices, R&d, Management, Project Management, Software Project Management, Change Management, Cross Functional Team Leadership, Manufacturing, Iso 13485, Engineering.

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