Jobs

Mechanical Engineer

Research & Development
Ref: 303 Date Posted: Monday 05 Aug 2019
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Company

 

Our client is a life sciences company delivering human-focused research and discovery enabled by a unique and proven Organ-on-a-Chip platform. They are at the forefront of the rapidly growing field of human Organs-on-Chips thanks in part to being a successful co-recipient with the Massachusetts Institute of Technology in 2012 of a $26M US Federal contract to develop the “Human Body-on-a-Chip”: a tablet sized device incorporating ten miniature interacting human organs.

The company is accelerating its development of new Organs-on-Chips instruments and consumables for the life sciences and laboratory instrumentation markets. To achieve this, the company is strengthening its new in-house product development team, which will be supported by external development and manufacturing partners.

 

Role

The company’s new products are expected to comprise a combination of laboratory instruments, consumables and accessories. Reporting to the Lead Hardware Engineer, the Mechanical Engineer will be responsible for contributing significantly to their development and transfer to manufacturing.

 

Responsibilities

Product – End-to-end development of mechanical components and sub-assemblies, delivering solutions suitable for volume manufacture. Support system integration in particular integration of electronic assemblies and interconnects. Testing to show compliance with requirements and achievement of required reliability. Development of manufacturing solutions with manufacturing partners, providing appropriate support through transition into manufacturing and in full production.

People – Establish and maintain effective relationships in the following key areas:

  • Peer engineers, scientists and technicians in other disciplines.
  • Key members of teams working for external development partners and suppliers.

Project Management – Support the company’s Program Management activities in areas relating to hardware development in the following ways:

 

  • Planning – Support planning of tasks, dependencies, effort and cost.
  • Risk Management – Support risk identification, evaluation and responses.
  • Execution – Ensure own work runs according to approved Program priorities and
  • plans. Devise appropriate responses to problems and issues.
  • Monitoring & Reporting – Periodically track and report progress by various means.

 

Quality Management – Work to requirements of design and development processes, achieving required safety, quality and regulatory compliance in all markets served, e.g:

  • Design Controls – Ensure all own development is compliant with the company’s
  • Quality Management System, including issue management, change control and
  • configuration control. As required, contribute to definition and deployment of new
  • or revised Standard Operating Procedures and Work Instructions.
  • Documentation – Ensure all development is documented to necessary standards.
  • Provide material as required to support regulatory submissions (e.g. CE Marking
  • Folder). Support review of other relevant documentation provided by others.
  • Regulations & Standards – Ensure that all development complies with requirements of external regulations and standards.
  • Design Assurance – Use of appropriate means to ensure that designs comply with
  • requirements and satisfy necessary standards.
  • Auditing – Support quality auditing in areas relating to mechanical engineering.

 

Selection Criteria

Qualifications - Bachelors Degree in Mechanical Engineering or Physics.

Experience:

Organization Types – Essential: Commercial environment (3+ years). Desirable: Scientific / laboratory instruments, medical devices, diagnostics. Start-up / SME business.

Product Types – Essential: Precision equipment, Medium volume, Medium-high value, Modular platforms, Multi-technology. Desirable: Instruments & Consumables, Microfluidics, Fluid Handling, Mechatronics, Pneumatics.

Quality & Regulatory – Essential:Design Control Processes forming part of a Quality Management System. Desirable: ISO 9001, ISO 13485, US 21 CFR 820 QSR, CE Marking (Medical Device /IVD), EU Low Voltage Directive

 

Technical Skills

  • CAD Highly skilled with 3D CAD modelling and generation of engineering drawings. Desirable: Solidworks.
  • Concept Generation - Rapid generation and communication of design concepts. Criteria-based evaluation and selection of design concepts.
  • Prototyping - Rapid prototyping methods (selecting and applying most appropriate for circumstances).Hands-on proof of concept testing.
  • Materials - Criteria-based selection for Technical needs, Production / Supplier capability, Regulatory compliance. Selection to satisfy needs for; Biocompatibility, Minimizing of absorption, Sterilization (multiple methods).
  • Reliability - Tolerance Analysis, Fault finding and root-cause analysis, Reliability planning /execution / analysis /reporting.
  • Standards - Design to requirements of international standards. Desirable; IEC 61010-1, IEC 60601-1, IEC 60950.
  • Manufacturing Methods - In-depth understanding of: injection moulding, precision machining (plastic and metal). Desirable: Injection Mould Tooling, Design or Casting.
  • Packaging & Labelling - Design of packaging and labelling for global logistics.
  • DFX - Design for; Usability, Manufacture, Service, Standards Compliance, Cost, Safety (inc Design FMEA), Reliability. Desirable: Industrial Design – Aesthetics, Branding, Design languages.
  • Design Assurance - Design Review, Testing (Prototypes & Production Designs). Desirable; Simulation & Modelling, e.g; Stress Analysis, Mould Flow Analysis, Computational Fluid Dynamics.
  • Quality Management - Document / Drawing Control, Specifications, Configuration Management, Issue Management. Test Plans / Protocols / Records / Reports.
  • Design Transfer - Bills Of Material, Release Packages and Production FMEA. Desirable: Production Process, Design and Supplier selection experience
  • IT - Microsoft Windows, Microsoft Word – including use for technical documentation. Microsoft Excel – including use for technical purposes, e.g. to determine component /sub-system performance requirements, model technical problems, statistical analyses, test records, etc and Microsoft Powerpoint.
  • Group Work / Presentational - Engages individuals and small groups using verbal, written and audio-visual material.
  • Intellectual Property - Patents / Registered and Designs.

 

Capabilities & Behaviours

 

  • Goals - Plans, executes and monitors own work to achieve commercial / quality / time /cost goals.
  • Organization - Organizes own work and shared working environment.
  • Prioritization - Appropriately values and prioritizes conflicting demands based on importance and urgency.
  • Achievement - Completer-Finisher – sees things through.
  • Relationships - Collaborates supportively and harmoniously with: - In-house multi-disciplinary colleagues, Geographically distributed development partners and Suppliers (local and global).
  • Communication - Communicates own ideas and points of view with conviction, where necessary acknowledging their limitations. Listens respectfully to views and ideas of others, embracing and developing them. Provides honest, respectful feedback (positive and negative).
  • Problem Solving - Applies a scientific approach, using fundamental principles and engineering theory to develop reliable product solutions. Demonstrate a “can-do” attitude, using logical and creative approaches to solve complex technical and project-related problems.
  • Risk Attitude - Risk tolerant – able and willing to deal with uncertainty, managing it effectively.
  • Professional - Strong sense of professional purpose – why they do what they do for a living. Proactively develops their skills. Actively aware of the ‘state of the art’ and developments in their technical discipline. Member of professional body. Chartered Engineer (or working towards it)
  • Travel - Current UK driving licence. Willing / able to travel internationally (occasional, typically 2-5 days).

 

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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