Group Lead - Instrument Hardware Engineering

eProtein Discovery is a breakthrough protein expression, characterization, and purification technology, consisting of a lab-based benchtop instrument, cloud-based software and proprietary cartridges and consumables. The goal is to enable rapid protein access to life science researchers around the world.

Reporting to the AVP of Instrument development, leading a multi-disciplinary engineering team, you will support commercial growth by:

• Being responsible for all hardware engineering aspects of Instrument development;
• Delivering new Instrument-based solutions to market;
• Enhancing existing Instrument hardware solutions;
• Supporting Instrument manufacture and service;
• Nurturing innovation.

About the role:

Instrument Design & Development – Whole life-cycle development of prototypes and commercial products, including:

• Requirements management
• Specification definition.
• Instrument Architecture design / definition of critical system interfaces.
• System Risk Management – Management of hazards and risk control measures.
• Using multiple technologies to control motion, fluidics, imaging, operating conditions.
• Simulation / multi-physics modelling.
• Design for prevention / management of contamination.
• Design of packaging and labelling to satisfy needs of global third-party logistics.
• Design For Manufacture & Assembly.
• Value engineering / Product cost management.

Technical Disciplines – Required competencies:

• Mechanical Engineering – Subject Matter Expert
• Optical Engineering / Electrical & Electronic Engineering – Able to understand and manage the work of senior level technical specialists / consultants.

Design Quality Assurance – Lead review, simulation, experimentation and testing of various kinds to ensure fitness for intended use, to include:

• System, sub-system, component level testing.
• Fluidic and in-vitro biological performance.
• Independent review / testing of Cartridge designs.
• Reliability modelling and testing.
• Type approval – Functional safety & EMC.

Instrument Manufacture & Service – Support volume manufacturing solutions, including:

• Design Transfer / Product Data Management using PDM and ERP systems.
• Design, deployment and improvement of production processes.
• Design and provision of manufacturing support tools.
• Authoring / review of build manuals and quality control procedures.
• Support supplier selection and evaluation.

Line Management – Responsible for multidisciplinary engineering team, to include:

• Recruitment / On-Boarding
• Appraisal / Performance Management
• Training / Professional Development

Key Relationships - Establish and maintain effective relationships in the following areas:

• Cartridge development and manufacture
• Workflow development
• Production / Logistics
• Product management
• Engineers, bioengineers, scientists and technicians in other disciplines.
• External development partners and production suppliers.

Processes – Define and implement design and development processes, sufficient to ensure the required safety, quality and regulatory compliance in all markets served.

Infrastructure – Selection, configuration and management of an appropriate collection of tools to support the full design and development lifecycle.

Quality Management – Designs to be developed in a defined manner to required standards:

• Quality Management System – Compliance with the company’s quality procedures. Define / revise 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. Technical Files). 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.
• Issue / CAPA Management – Provide an effective means by which issues occurring in development, or the field, will be recorded and appropriately managed.
• Change & Configuration Control – Manage change to ensure that all product configurations are properly managed through development and use in the field.
• Auditing – Act as a company representative in quality audits.

• Health & Safety Compliance – Ensure self and all direct reports remain up to date with H&S training, and operate in a manner that is compliant with all H&S requirements.
• Information Technology - Remain up to date with applicable training. Work in a manner that is compliant with company information security and data protection requirements. Ensure the same for all direct reports.

Project Management – Acting as a ‘Player/Manager’, lead and support projects as follows:

• Pitch / Proposal – Generate and advocate credible value-aligned project proposals
• Planning – Provide plans covering tasks, dependencies, effort, cost and resource allocation. Support review and integration into overall Portfolio structures.
• Risk Management – Lead / support risk identification, risk evaluation and choice of appropriate risk response strategies.
• Execution – Ensure day-to-day running in accordance with approved priorities and plans. Devise appropriate responses to problems and issues.
• Governance – Periodically track and report progress by various means, covering deliverables, adherence to schedules, actual spend vs budget, etc.

Technology Management – Aligning with the company’s value-creation strategy, support development of company’s technical capability in the following areas:

• Technology Sourcing – Initiating / supporting sourcing of technologies.
• Technology Evaluation – Support review and test of external technology offerings.
• Technology Partnering – Support technology collaboration and transfer.
• Technology Creation – Initiate / nurture internal innovation and IP management (including Invention Disclosures and Patenting).

Engineering Laboratories & Workshop – Responsible for safety, good housekeeping and ensuring fitness for purpose, including management of improvement projects.

Requirements

Essential:

• Bachelor’s degree in Mechanical Engineering, Physics, Materials Science.
• Has provided full life-cycle technical leadership for development of 2+ complex multi-technology products, satisfying demanding performance requirements and complying with standards controlling development process and documentation.
• Has carried team lead responsibility for 3+ years. Experience of managing outsourced development desirable.
• Industry experience within medical devices, diagnostics or laboratory instruments.
• Extensive experience in 3D modeling using SolidWorks / PDM and material selection (including biocompatibility).
• Experience prototyping using variety of techniques.
• Experience tooling design for injection moulding.
• Maintenance of Bills of Material (including volume costings).
• Experience with technical /design review.
• Good computing competency, act as administrator for specialised applications.
• FMEA (Design)

Desirable:

• Industrial design / ergonomics (collaborative work with appropriate consultants).
• Simulation & Modelling (including Stress Analysis, Mould Flow Analysis).
• Manufacturing Process Design
• Design For Excellence
• Value Engineering / Cost management
• FMEA (Production)
• Structured problem solving / improvement, e.g. DMAIC, 8D.
• Optical engineering principles
• Design Controls / Stage-Gate Development

Benefits

What we offer - In addition to competitive salaries, we offer a range of benefits including:

• Share option incentive scheme
• Life insurance
• Private medical insurance and cash plan
• 25 days' annual leave + Bank Holidays
• Enhanced employer's pension contributions
• Enhanced maternity and paternity Leave
• Investment in professional development and learning
• Fresh fruit, tea, coffee, and snacks in the office
• Organised social events for staff