Senior design engineer

Welland Medical, one of the leading ostomy brands in the UK and worldwide, specialise in the design, development and manufacture of innovative stoma care appliances and accessories. Welland Medical is renowned for manufacturing ground breaking solutions that enhance people’s lives, every day. Situated in a purpose-built state of the art research, development and manufacturing facility, Welland Medical has a growing workforce of over 240 skilled colleagues. Part of the privately owned CliniMed Group, which established in 1982, provides specialist products and services to the healthcare market.

Overall Purpose of the Role:

The successful candidate will be working as part of the Research and Development team, to design, develop and deliver Medical Devices for Ostomy Care. The candidate will be involved in the New Product
Development process, helping to conduct primary research, generate and evaluate concepts, support product verification and validation and complete design and drafting work using SolidWorks. The role will
also require working closely with the wider business to support transfer to manufacture, marketing activites, and registration processes required to sell Class 1 medical devices.

Our R&D team of Engineers, Designers and T echnical experts are at the forefront of technology in the ostomy device industry. You will be making a vital contribution to Welland’s New Product Development
process and transforming patient care through innovation. As a Design Engineer you would be involved in specific & general assignments/projects that provide innovative, functional, cost effective & validated
product designs in a team-based environment.

As a Senior Design Engineer, you be working as an integral part of the Development team and be responsible for the day-to-day development of new products, as well as improving existing products as part of continuous improvement. As well, you will help support market analyses and suggest viable technologies to be invested in based upon your own experience and research. You will also lead testing procedures for prototypes before they are passed to the project and engineering teams.

You will have significant technical knowledge and experience of Research and D evelopment and be accustomed to working to industry or ISO standards. The Senior Design Engineer’s expertise is essential
to their responsibilities to provide technical guidance and support to the team and lead complex technical projects.

Key Responsibilities of the Senior Design Engineer:

As a Senior Design Engineer, you will work in all stages of the design process, from early user insight analysis through to ideation, concept development, detailed design, and final product testing and validation.

Additionally, you will:

• Support all NPD activity, and assist project progress through transfer to manufacture, production and launch.
• Preparation of detailed component technical drawings, documentation to BS8888 (BS308) using SolidsWorks CAD.
• Use and maintain PDM/design history files.
• Evaluate potential IP infringements and opportunities
• Consideration of Marketing requirements, patient and customer needs, human factors/usability, environmental factors and design for manufacturing and assembly.
• Adherence to Quality Management System (QMS) requirements in line with ISO13485 and the MDR
• Lead product development projects throughout the product lifecycle
• Developing physical prototypes to test and validate ideas and concept proposals
• Perform feasibility analysis on design plans or early phase KPI projects.
• Product verification and validation
• Creating and reviewing technical reports.
• Produce and validate Technical Specifications.
• Use of DFMEA principles to minimise design risk
• Solve complex design problems and support production issues in relation to products and their performance
• Consideration for Design for Manufacture
• Support Change Management within the organisation and within development team specifically
• Establish design-related methodologies for testing.
• Evaluate analysis findings for technical and business reports.
• Providing technical support and maintenance for the existing Welland Medical product range.
• Provide support as the technical authority of the Welland Medical’s product portfolio both internally and externally.
• Ensuring designs are cost-efficient, mechanically feasible and manufacturable whilst firmly protecting and communicating the design intent and creative vision of the product.
• Technical liaison with the customer/s and attendance at Sales & Marketing and Research & Development meetings, helping to provide technical solutions and products support, this may involve distributor meetings and visits to our global markets providing training, research support with co-creation.
• Experience in providing cross-functional links between Technical, Marketing/Sales, Quality, Regulatory, Manufacturing departments, and external customers/suppliers and other key stakeholders.
• Liaising with and communicating issues and design status to designers, suppliers and various cross-functional teams within the business.
• Mentoring and guiding less senior and student team members as required.
• Maintaining and championing Welland’s commitment to high quality product standards and reliability benchmarks
• Supporting QA/RA in technical investigations of customer complaints and in compilation of technical sections of regulatory submissions.
• Understand the principle of Lean Manufacturing and CI

Other Duties:

A degree of flexibility is needed, and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the senior level of the role.

As a Senior Development Engineer, you will have:

• A Bachelor’s degree in a relevant subject. Eg.s Product/ Industrial Design, Mechanical Engineering, Biomedical Engineering or demonstrate a similar level of academic/ work experience
• Minimum of five years Design Engineering/ Product Design experience in a product development role, but more importantly, a passion for design, a commitment to learn, a willingness to share ideas and facilitate free and open collaboration.
• Aptitude for design and development, strength in both concept design and detail drafting.
• Familiarity with 3D CAD and associated analysis tools, SolidWorks (similar) literate to a strong level
• Strong technical/ Innovation background in delivering projects from concept through to manufacture with a thorough understanding of the product development process.
• Excellent problem-solving skills with the ability to identify and analyse problems and generate design solutions in compliance with design specifications through root cause analysis.
• A high level of computer literacy.
• Excellent planning, organisational and time management skills.
• Effective decision-making skills.
• Be highly motivated, proactive, and capable of working with minimum of supervision.
• Good team working skills.
• Good written and verbal communication skills.
• The drive to explore, always looking for new ways of doing things, with a passion for investigating different processes and technologies from various innovation fields and translating and implementing those ideas into new product offerings.
• Good understanding of manufacture principles for high-volume consumable products
• Experience of Engineering analysis and a working knowledge of FMEA and DFMA
• Design experience from within the medical device field would be an advantage, however, is not a pre-requisite for the Senior Design Engineer role; all product design experience is valued
• Experience of working to design and manufacturing standards such as ISO9001 or within the medical device industry, MDR, ISO 13485 and FDA Design Control is desirable.
• Leadership/ Coaching/ Mentoring skills are essential.

Health and Safety:

The Company has a Health and Safety policy, which outlines responsibilities of both the employer and employee in respect of health and safety. All employees are required to be aware of this policy and
comply with its content fully.

Quality:

Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and
procedures.

Continuous Improvement:

The company is committed to a culture of continuous improvement. All members of staff are expected to take ownership of tasks and seek new and improved ways of doing things.

This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.

For more information, please contact our recruitment team at recruitment@wellandmedical.com.

A covering letter and CV are required with all applications.