We are actively looking to recruit a Medical Device Design Engineer to be part of TISSIUM’s Surgical Instrumentation Team. This person will support the ideation and design of surgical instrumentation to be used in conjunction with TISSIUM polymer implants in a variety of clinical scenarios and ensure designs meet the needs of our customers and target markets. The Medical Device Design Engineer will report to the Head of Surgical Instrumentation Design.

DUTIES & RESPONSIBILITIES

(Principle accountabilities)

• Development of project/design inputs using, but not limited to, the User Story & Usability processes.
• Lead the conceptualisation, evaluation and iteration of ideas through virtual or rapid prototyping, formative usability, theoretical and physical analysis, maximising the opportunity for key stakeholder input, in close collaboration with the New Concepts and Product Development teams (requirements to meet customer, clinical, functional and manufacturing requirements).
• Support the evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering analysis and testing in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements.
• The delivery of manufacturable designs acceptable to operations by applying Design for Manufacture (DFM) and Design for Assembly (DFA) principles and feedback from product development, manufacturing engineers, external suppliers and other sources.
• Generation of 3D models & 2D technical drawings that communicate accurately and concisely the design and manufacturing requirements.
• Coordination of vendor activities relative to communication of specifications, development schedules and progression tracking to obtain components, supplies or equipment to support prototype or product procurement and assembly.
• Maintain a strong understanding of new product development, prototyping and manufacturing technologies and their application to medical device development.
• Generation and review of design history file documentation in compliance with Quality System Regulations (QSR), International Standards Organisation (ISO) and company requirements throughout the project life cycle to ensure the design is fully documented.

ENVIRONMENT & INTERACTIONS

• Work closely with Tissium’s different departments to understand the product development process.
• Present results in team meetings
• Can foster/influence the development of new ideas and creativity at TISSIUM

QUALIFICATIONS & SKILLS

• Bachelor’s degree in an appropriate Engineering discipline or equivalent with a minimum of 3 years’ experience in a highly regulated, mechanical engineering design environment.
• Certified SolidWorks Expert (CSWE) or Professional (CSWP) qualification; highly desirable. 2 - 4 years of daily experience using Solid works – an advanced user that can design, analyse parametric parts and moveable assemblies, using a variety of complex features within Solidworks.
• Strong understanding on different approaches to problem solving, ideation and new concept generation.
• Understanding of a wide range of engineering technologies used in design and manufacturing.
• Knowledge of mechanical design relating particularly to mechanisms.
• Knowledge of how to articulate complex and conceptual information to others in a meaningful and relevant way.
• Knowledge of design development within a Medical or other highly regulated industry.
• Strong knowledge of rapid prototyping technologies and their application.
• Strong knowledge of current drawing standards and practices for the generation and maintenance of technical drawings.
• Fluent in English

COMPETENCIES & PERSONAL ATTRIBUTES

• Curious and creative in approaching technical challenges.
• “Can do” attitude.
• Organized, rigorous and team player.
• Hands on approach.
• Passionate about improving peoples’ and patients’ lives.