Managerial Competencies

Line Management: 

Responsible for 24 multiple discipline team members: Mechanical, Electrical, Software and Robotics.

Best Practice: 

Identified areas that effected our delivery of projects: time, budget, quality, and stakeholder engagement. I then turned the solution into a procedure, to be implemented as a best practice improvement to the way we worked.

Procedure Setup: 

Template creation and training in line with auditable Design History File to medical regulatory standard for Verification & Validation activities, Requirements Capture, Applicable Standards, Technical Reports and 

Testing Protocol.

Task Management: 

Implemented/modified new software in order to create time & task tracking, to ensure project budget and client deliverables were achieved, as this is critical in a consultancy where time is the product.

KPI’s: 

Setup and identification of department and individual KPI’s.  Created system to track and monitor KPI’s that enabled a retrospective look during a Lesson Learnt to put in place department Strategies, Polices and team member improvements.  

HR Resource: 

Support management ensuring adequate staffing levels, managing holiday allowances, recruitment, training, development, appraisals, attendance, disciplinary issues, and daily supervision to maximize efficient and effective productivity.

Self-Management: 

I endeavor to show to the team, resilience, strong leadership through a challenging time, optimism and openness to change.  While I am action oriented with a task driven focus, I strive to maintain high levels of team motivation.

• Focused on continuous professional development (skills and behavior).  
• Completed Machinery Safety Directive course.
• Gained IOSH Managing Safety qualification. 
• Completed Workplace Mental Health course to aid the pastoral care element of my role.

Variety Of Projects: 

Being a Design Consultancy I have led the design on a wide variety of projects, to include Medical Devices (Microprocessor Knee), Consumer Devices (wrist warn device) and Industrial Products (mobile Crane).

Feasibility Study: 

Created feasibility studies that answered key technical questions to ensure we can engineer and deliver the project to specification. Delivering client Q&A, identifying project risks and creating plan of action for next steps.

Aesthetics vs Functionality: 

Clients came to us with highly stylized underdeveloped conceptual concepts.  I was able to transform these concepts into functional production ready designs while keeping true to the aesthetic form & quality.  

Requirements Capture: 

Challenged client briefs and initial requirements to capture potentially unforeseen design challenges & applicable standards to create a robust “Must/May/Should” Requirements Specification document.

FEA: 

Utilized FEA analysis in the creation and validation of my designs. To include a structural Crane design. Also, system sealing design with environmental thermal expansion stack and system induced bending due to dynamic structural loading.

Root Cause Analysis: 

Conducted design reviews and root cause analysis on dynamic mechanical systems to resolve issues with existing designs.  Modified these designs then re-evaluated and analyzed again until design meets specification.

Leadership: 

Before introducing a project to the team, I ensure I have already a Solution Outline and Engineering Concept in mind or on paper with a detailed plan and task deliverables.  This facilitates collaboration, coaching and targeted guidance.

Project Management: 

Creation of detailed programs encompassing critical path, risk options, milestones and verification and validations activities. Co-ordinating and overseeing workloads. Assist sales team with providing time and cost estimates.

• GD&T BS8888 drawings. 
• 3D CAD design using SolidWorks. 
• Critical To Function feature analysis.  
• System level Tolerance Stack. 
• Department KPI’s. 
• Engineering Procedure Setup. 
• HR Resource considerations. 
• HR legal considerations.

Project Meetings:                                                   

Lead meetings with the multi-disciplined team members.

Detailed Work Plans:                                                        

Create detailed project work plans and GANNT for each stage of the.

System Architecture:                                                           

Advised on best product system architecture that integrates the marketing & Functional requirements. 

Regulatory Submission:                                                     

Ensured compliance for medical standards / directives and ISO13485 and FDA21 CFR Part 820.

Audit:                                                                             

Successfully passed FDA audits of my Design History File ensuring we maintain our regulatory status in the US.

Risk Minimization:                                                        

Creation and overseeing of design risk mitigation activities which is critical in the implant.

Budget Management:                                                 

Managed the project budget to include initial manufacturing and design verification prototypes.

Resource Utilization:                                                      

Calculating people resource allocation and utilization for multiple projects.

Managing Multiple Projects:                                                  

I worked on multiple projects simultaneously with project values of approx. £1.3m.

Board Meetings:

Presenting to the board project issues, mitigating actions, stakeholder, and Stage Gate agreement.

Cross Functional Team:                                                        

Lead In-house team from Design to Manufacturing to sales, FEA and subcontractors in UK and US. 

Lead Engineer:                                                           

With my core skillset as a Mechanical Engineer alongside my Project Management duties I stepped into the role as the Lead Engineer to help steer the design and support the project with Engineering resource.

CE / FDA Approval:                                                         

Lead design Engineer responsible for the Implant insert design from concept through to production and Project Management of the cross functional team and successfully acquired CE and FDA approval of the product.

3D CAD Surface Modeling:                                        

Created kinematic articulation surface CAD model for Implant design using NX.

Design For Manufacture (DFM):                              

Incorporated inputs from design review meeting with Production Engineers to ensure my designs are fit for DFM to optimize the machining for our inhouse production facilities.

Drawings:                                                                      

When generating technical drawings, I ensured Inspection departments capabilities are aligned with the CTQ (Critical To Quality) dimensions I had specified and cross referenced to my generated Verification Plan.

Concept Generation:                                                   

Generated multiple concepts based on learning research from Medical Papers, best practice Engineering principles for Bio-Mechanics and Kinematic design for dynamic forces.

Test House:                                                               

Created test fixtures for our inhouse facilities to aid in the Validation and further development of my designs. This included generating the Test Protocols and CAD generation of test fixtures for the LAB.

Report Writing:                                                          

Writing test reports for the Validation of my designs that were submitted to the FDA and CE regulatory bodies for scrutiny for the qualification of my designs. 

Medical Literature Review:                                            

Utilized medical research papers and literature reviews to verify designs analytically to ensure in line with peer reviewed medical science research, that in turn supported later submission for FDA regulatory approval.

Client Facing:                                                               

Traveled to the US to Lead client facing meetings with Surgeons to deliver technical presentations to communicate and agree user requirements, project scope and design specification and concept of my designs.

• Completed Project management training.
• Completed ANSYS training.