Design Engineer II

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 to be a part of research and development workstreams, subsystems and/or specific products and deliverables in the domains ranging from simple disposable devices to complex thermos-fluidic system and sophisticated robotic solutions involving IT connectivity, machine learning and AI.

As an R&D engineer you will be a part of the product development and engineering department, you will report directly to the R&D Director Product Engineering. 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 the scope of 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 associate with surgical devices, instruments, and disposables in broader women’s health field including Obstetrics and Gynecology (OBGYN). the Global Cooper Surgical R&D organization and you may as needs arise 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 analyze / simulate design to understand key parameters and sensitivities. Establish design feasibility by testing circuit and demonstrating statistical capability for critical functions.

  Define design inputs (., product requirements), develop design outputs (., product specifications), define technical strategies for an adequate verification and validation approach. Drive successful verification and validation testing.

  Ideate, conceptualize, and build concepts and prototypes to aid incubation of new opportunities or down-select wining solutions for new product developments, upgrades, or improvements.

  Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solution 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 (solution gameplan) 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, run tests, and write 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 organization 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.

  project tasks, workstreams, and deliverables ensuring full alignment with the overall project plan and business objectives.

  Participate in design review and DFMA activities.

• ORGANIZATIONAL AND PROCESS EFFECTIVENESS

  Aid in the 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 (IP’s) 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.

• 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 and 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 modeling.

• 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 modeling – preferred.

• Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria – 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.