Design Engineer II in Falmouth

This Engineer is a skilled professional responsible for contributing to engineering projects and collaborating with cross-functional teams to design, develop, and implement solutions. You will play an essential role in ensuring the successful execution of engineering tasks and projects to tight time scales and ensuring functional and non-functional requirements are met. This opportunity involves research and development workstreams, subsystems and/or specific products and deliverables in domains ranging from simple disposable devices to complex thermos-fluidic systems and sophisticated robotic solutions involving IT connectivity, machine learning, and AI.

As an R&D engineer, you will be part of the product development and engineering department, reporting directly to the R&D Director Product Engineering. The scope of this role includes activities pertaining to sustaining activities, new product development, product upgrades and improvements, line extensions, as well as new concept incubation activities. Within this role are electro-mechanical connected systems and devices associated with In-vitro fertilization (IVF) and Assisted Reproductive Technologies (ART). You will also have an opportunity to contribute to product development and sustaining engineering activities associated with surgical devices, instruments, and disposables in the broader women's health field including Obstetrics and Gynecology (OBGYN).

In this role within the Global Cooper Surgical R&D organization, you may be asked to support other areas of the business to ensure the success of the company in line with the 'One Cooper' philosophy.

• Technical Contributions: Design and develop components and assemblies using first principles. Lead development of product or sub-systems for complex electromechanical products and analyse/simulate design to understand key parameters and sensitivities. Establish design feasibility by testing circuits and demonstrating statistical capability for critical functions. Define design inputs (i.e., product requirements), develop design outputs (i.e., product specifications), define technical strategies for an adequate verification and validation approach. Drive successful verification and validation testing. Ideate, conceptualise, and build concepts and prototypes to aid incubation of new opportunities or down-select winning solutions for new product developments, upgrades, or improvements. Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solutions based on experimental, numerical, statistical, and/or finite-elements tools and techniques. Participate in troubleshooting, root-cause analysis and devise solutions and approaches for solving technical problems and overcoming development challenges in an inclusive and collaborative fashion. Develop test methods and fixtures for products, components, and systems simulation, evaluation, and verification testing including creating formal Verification test protocols, running tests, and writing Verification test reports. May communicate key technical content to parties within and outside of own function (R&D). May have responsibility for communicating with parties external to the organisation and manage external development partners to meet project deliverables on time.
• Project Delivering: Deliver agreed project outcomes on-time and on-budget per project plan. Manage your assigned project tasks, workstreams, and deliverables ensuring full alignment with the overall project plan and business objectives. Report to Project lead on your assigned tasks, ensuring early escalation and identification of project risks. Participate in design review and DFMA activities.
• Organisational and Process Effectiveness: Aid in effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes. Contribute to the assessment of new opportunities, acquisition targets, competitive products, and Intellectual Properties (IPs) to aid competitiveness and differentiation of our business offerings. Support scoping, project planning and product requirement definition for new product development, upgrades, or line extensions as appropriate. Contribute to the selection, evaluation, and implementation of new tools, techniques, and best practices to ensure state-of-the-art product development capabilities and best practices. Effectively and timely communicate (written and verbal) progress status updates associated with project issues.
• Safety, Efficacy, and Compliance: Ensure adherence to medical devices design control compliance by ensuring all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective products. Maintain technical documentation for project and products as applicable per company quality standards, policies, and procedures as well as engineering best practices and functional excellence requirements.

• MEng or BEng (Hons) Degree or equivalent.
• Highly Proficient in engineering designs and creation of engineering drawings – required.
• Medical device development experience with thorough understanding of design control guidelines including verification and validation methods – required.
• Proficiency with engineering first principles and analytical methods including simulation modelling.
• Understanding of Design for Manufacturing and Assembly (DFMA) – required.
• Understanding of statistical methods including design of experiments – required.
• Hands-on craft skills and experience with building, fixing, servicing and/or fabricating concepts, fixtures, prototypes or similar – required.
• Experience with FEA and/or simulation mathematical modelling – preferred.
• Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria – preferred.
• Experience with electro-mechanical, robotic, or digital systems – preferred.
• Experience with Design for Six Sigma (DFSS) – preferred.
• Experience in drafting testing protocols and reports – required.
• Experience with identifying latent user needs and front-end of innovation process – preferred.