Senior R&D Engineer
Senior R&D Engineer
Location: Danvers, MA, USA
Type: Full Time
Leddy Group is searching for a Senior R&D Engineer in the Medical Device Industry. This is a Senior role within the R&D department that is responsible for developing technology & strategies for new products that drive down manufacturing cost and/or lead times, and meet market needs. You will also provide leadership for cross-functional teams and identify opportunities to improve existing products and procedures. In addition to in house work, you will interact with clients and the market to understand and translate customer needs into product requirements and design specifications.
Senior R&D Engineer Responsibilities:
- Designs, develops, analyzes and documents product designs, and assesses the feasibility and soundness of proposed products, evaluation tests, and equipment in accordance with ISO, FDA and corporate design control guidelines to produce the highest quality product.
- Works cooperatively with marketing, quality, manufacturing, regulatory and other functions , as a project team leader, throughout the New Product Development to ensure success.
- Identifies critical technical challenges, defines schedules, assigns tasks and quantifies progress of an R&D team against project goals and accurately predicts the time required for project tasks.
- Represent the company and R&D department in technical conferences, committees and meetings with medical professionals, technologists, attorneys, etc. Interfaces with Physicians to obtain feedback on concepts and performance of new devices.
- Successfully completes complex engineering work and documentation in one or more of the following: product design and development, technology development, test of materials or products, process study, research investigation (animal and clinical studies), preparation of specifications, and report preparation.
- BS or MS in scientific / technical discipline (such as Mechanical, Electrical Engineering)
- 6-10 years of related experience in the medical device industry developing Class II Medical devices
- 3 years of Technical Management or Project Leadership experience
- Must have demonstrated knowledge of regulations and standards effecting medical product development.
- Knowledge of ISO, FDA, GMP and design control process is required
- Demonstrated knowledge of Product Design for Assembly (DFA). Experience incorporating Boothroyd & Dewhurst methods a plus.
About Leddy Group
We are Leddy Group… a privately owned, regional staffing company serving NH, ME, VT & northern MA. One great brand… multiple specialties in accounting and finance, administrative and executive assistants, engineering, human resources, industrial and skilled manufacturing, and office support and customer service.
At Leddy Group we combine a consistency of values and traits with a singular standard for quality and best practices. We hold each other accountable to those standards, measure success by the quality of our outcomes, and establish goals based on continuous improvement metrics. This is the compass which leads us to put the right people in the right places. Methodology and process to assess skills and experience. Focusing on fit, company, and culture.