Our client, a designer and manufacturer of surgical equipment and solutions, is looking for an experienced Senior R&D Engineer. This is a senior tech-lead role within the R&D department and provides leadership for cross-functional teams to design and develop new products that drive down manufacturing cost and lead times and meet market needs. The candidate is responsible for developing technology & component strategies for new products, while also identifying opportunities to improve existing products. The R&D Engineer will be developing new technology, products, materials, processes, or equipment with minimal supervision. Working independently, or as a member of a team, the Engineer will develop, direct and execute plans for a major segment of complex projects.
- Translate customer needs into product requirements and design specifications.
- Consistently generate innovative and unique solutions to market needs and submits idea disclosures resulting in the development of new or refined products, processes, or equipment.
- Interface with Physicians to obtain feedback on concepts and performance of new devices.
- Work cooperatively with marketing, quality, manufacturing, regulatory and other functions on complex projects to ensure successful New Products to be developed.
- Coordinate, manage and document project goals and progress of an R&D team and recommends appropriate actions.
- Assess the feasibility and soundness of proposed products, engineering evaluation tests, and equipment.
- Responsible for engineering documentation, especially Design History File (DHF).
- Successfully completes complex engineering work and documentation in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
- Select techniques to solve complex problems and makes sound design recommendations.
- Summarize, analyzes, and draws conclusions from complex test results.
- Design and prepare complex reports to communicate results to technical community.
- Designs and coordinate complex engineering tests and experiments
Areas of Focus:
New Product Development
- Research and analyze information such as customer requirements, standards, and industry trends to determine feasibility of design or application.
- Interface with health care professionals on product requirements.
- Designs, develops, analyzes, and documents product designs in accordance with ISO, FDA, and corporate design control guidelines
- Coordinate and lead a cross-functional team from prototype stage through pilot manufacturing including manufacturing process validation.
- Knowledgeable in state of the art manufacturing processes (plastics, 3-D printing, etc.)
- Perform and report on evaluation testing, verification, and validation in accordance with ISO, FDA, and company design control guidelines.
- Knowledgeable on design for reliability
- Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives.
Communication and Leadership
- Serve as the project team leader throughout the New Product Development process, identifies critical technical challenges, defines schedules, assigns tasks, and quantifies progress against project goals.
- Effectively communicate information to peers, customers, and suppliers in order to facilitate project goals.
- Serve as a mentor to other engineers in the company, helping them to develop their design, analysis, and problem-solving skills
- Represent the company and R&D department on behalf in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc.
- Utilize company design control procedures and project management techniques to effectively drive development of new, high-quality devices, or product improvements.
- Adhere to all company policies, rules, procedures, and housekeeping standards
- BS or MS in scientific / technical discipline such as Mechanical, Biomedical Engineering
- Minimum 6-10 years of related experience in the medical device industry developing Class II Medical devices
- Minimum 3 years of Technical Management or Project Leadership experience
- Must have demonstrated knowledge of regulations and standards effecting medical product development.
- Experience translating customer needs to product requirements; and developing DHF deliverables like Product-spec, Risk Management, Verification & Validation, etc.
- Strong ability to interact and collaborate with physicians in the field, preclinical studies, with hands-on capability in the lab
- Knowledge of ISO, FDA, GMP and design control process is required
- Knowledge of IEC standards and testing.
- MEs must be proficient in Solidworks.
- Demonstrated knowledge of Product Design for Assembly (DFA)
- Experience as project Core Team Leader
- Experience developing Electro-Mechanical Products for Minimally invasive surgery
- Demonstrated technical decision making
- Proven success with delivering Manufacturable concepts to Production and launch into market
- Effective communication skills required due to support of cross functional projects within a team