Senior Mechanical Engineer

TN United Kingdom; Comber; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Senior Mechanical Engineer to join their R&D team. The role involves developing innovative medical devices, ensuring compliance with relevant standards, and contributing to the New Product Development process. Ideal candidates will have a degree in Mechanical Engineering, significant experience in the field, and expertise in design verification and validation.

Qualifications

• Experience in a similar senior role within the Medical Devices sector.
• Ability to progress designs through the NPD process.
• Experience with polymer processing and joining methods.

Responsibilities

• Contribute to the development of new medical devices.
• Lead the development of test programs for new devices.
• Provide mechanical engineering knowledge for R&D activities.

Skills

Design verification and validation

Engineering theory application

Test method development

Multi-functional teamwork

Time management

Education

Degree in Mechanical Engineering

Post Graduate qualifications (e.g. Master's)

Tools

3D parametric CAD systems (SolidWorks)

Job description

Social network you want to login/join with:

The Senior Mechanical Engineer will join a busy R&D team that includes formulation and material scientists, designers and mechanical engineers who share a common goal of developing the next generation of medical devices in the areas of ostomy, respiratory and surgical instruments.

KEY ACTIVITIES

• Contribute to the development of new devices, from early stage product concepts to ready for clinical trial product, in line with Eakin Healthcare’s development strategy, Quality system and New Product Development (NPD) process.
• Resolve design changes with adherence to the relevant standards (e.g. ISO13485, MDR etc).
• Contribute as a team member to allocated work-streams within development projects, to meet project targets and ensure end product meets with customer expectations and operational needs.
• Provide input to and author technical reports and design documentation for internal and external users to review, ensuring that the content is accurate and informed.
• Adopt a continuous improvement approach by proactively seeking out development opportunities by learning and attending training courses to ensure that the department has the right skills to deliver on relevant business needs.
• Provide mechanical engineering knowledge as an input to R&D activities and business decision making within speciality areas.
• Provide leadership in the development of theoretical/analytical/mathematical models of systems or components to better understand and predict the operation of new medical devices and to quantify product specification parameters and acceptance criteria.
• Lead the development of Test programs for new devices, systems and components.
• Inform Design for Manufacturing and Assembly (DFMA) assessments to ensure that the parts that will form a product can be reliably and repeatedly manufactured and assembled.
• Guiding the selection of materials backed up by a sound understanding of how they are predicted to work in the field.

Other

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy.
• To adhere to the company’s Quality policy and Environmental policy.
• To undertake other duties as may be reasonably required.

KEY SKILLS

• Previous experience in a similar role at a senior level.
• Educated to Degree level , or equivalent, in Mechanical Engineering.
• Ability to progress medical device designs through the NPD process with a focus on design verification and validation activities.
• Ability to resolve design changes with adherence to the relevant standards (e.g. ISO13485, MDR etc)
• Significant experience in a similar role at a Senior level within the Medical Devices sector, preferred.
• Can demonstrate expertise in the application of engineering theory to real world problems (e.g. FEA, FMEA, DFMA, Tolerance Analysis, Strength of Materials, Fluid Mechanics etc.)
• A focus on developing and validating test methods applicable to medical devices with a working knowledge of experimental diligence and the ability to collect, analyse and interpret data.
• Can contribute to business critical decision making during the NPD of medical devices.
• Be able to work in a multi-functional team and to build relationships with peers.
• Have an ability to manage own time and work in a fast-paced environment and on multiple projects running concurrently.
• Further Post Graduate qualifications such as a master’s degree
• Have experience of polymer processing and polymer joining methods
• Experience of lab equipment allied to the polymer or adhesives industries
• Experience in specification of injection moulding processes
• Expert in 3D parametric CAD systems such as SolidWorks

KEY WORKING RELATIONSHIPS

Internal

• Working within the Development team to provide leadership in the down selection of designs via theoretical modelling, testing, decision matrices, tolerance analysis, risk analysis, design of experiments or other relevant techniques.
• Working alongside the Test Engineer(s) to ensure test programmes have identified and are recording the relevant metrics.
• Working alongside the Industrialisation Engineer(s) to support the realisation of new products in a volume manufacturing environment.
• Working alongside Operations colleagues to ensure the impact of technical decisions are understood fully by manufacturing.
• Working alongside the Commercial team(s) to understand the commercial implications of technical decisions.
• Quality - ensuring all documentation is of an appropriate and consistent standard.

External

• External Consultants
• Universities
• Test houses

ADDITIONAL INFORMATION

• Occasional travel may be required to other Eakin sites.

COMPETENCIES

Customer Focus
Building strong customer relationships and delivering customer-centric solutions.

Decision Quality
Making good and timely decisions that keep the organization moving forward.

Plans and Aligns
Planning and prioritizing work to meet commitments aligned with organizational goals.

Ensures Accountability
Holding self and others accountable to meet commitments.

Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.

Persuades
Using compelling arguments to gain the support and commitment of others.

Instils Trust
Gaining the confidence and trust of others through honesty, integrity and authenticity.

Situational Adaptability
Adapting approach and demeanour in real time to match the shifting demands of different situations.