Sr. R&D Engineer/Principal Research and Development Engineer

Our client is looking for a Senior/ Principal Engineer, R&D who will be responsible for product development. Working closely with cross-functional team members, the individual will discover new product opportunities and lead projects to develop concepts and bring them to launch.

This position will work remotely but will require you to come to any of our sites and/or customer sites, as needed. Given that, the successful candidate is required to live within 2 hours of Lincolnshire IL office. *****

ESSENTIAL DUTIES and RESPONSIBILITIES:

• Discover unmet customer needs related to acute clinical care
• Research and summarize current and emerging characteristics of hospital environment, procedures, staff, workflow, technique, and equipment
• Participate in Voice of Customer research, including creation of plans, materials, and analysis
• Visit health care facilities to observe clinical setting and procedures
• Prioritize and summarize customer needs and opportunities to provide new benefits
• Develop concepts for novel products and features to enhance medical care and workflow
• Lead activities to generate, collect, and prioritize ideas
• Research materials, production methods, and technologies for potential product designs, and assess cost and performance feasibility
• Create concept models to represent and communicate new product concepts and features
• Collect and use feedback to iterate, refine, and select concepts
• Collaborate with team to analyze and summarize final concept, value to customers, and project plans
• Lead cross-functional activities to fully design and launch new products
• Serve as project leader and coordinate project teamwork via plans, communication, and records
• Subject matter expert on FDA and ISO Design Controls regulations and company procedures, and complete all necessary documentation
• Develop and document project plans, user needs and design requirements, detailed design specifications, testing, supplier and manufacturing development, risk management, and regulatory activities.
• Engages outside design firms, testing labs and technical consultants to apply specialized expertise to projects.
• Engage outside design firms, testing labs and technical consultants to apply specialized expertise to projects.
• Uses advanced techniques, theories, and processes to identify and develop new products.
• Mentor other engineers to develop problem solving and technical expertise.
• Performs other tasks, as required or directed.

QUALIFICATIONS:

• BS Engineering Degree (Mechanical, Biomedical, or Material-Science preferred).
• A minimum of 8 years' experience developing new products as an engineer in a medical device company.
• Experience in medical device under FDA 21 CFR 820.30 Design Controls, ISO 13485 and ISO 14971 Risk Management.
• Previous participation in Voice of Customer research, brainstorming and ideation of early-stage product development.
• Demonstrated engineering, analytical, problem solving, and technical skills.
• Effective written and oral communication in English language.
• Successful team player; demonstrated successful interpersonal and influence management skills.
• Proven track record of leading R&D projects from conception to delivery.
• Experience with user centered design principles, tools and techniques and usability engineering.
• Proven ability to analyze, synthesize, and summarize complex data about customer needs and translate insights into new product opportunities.
• Creative and resourceful at creating new product concepts and solving problems.
• Demonstrated ability to construct prototypes and concept models.
• Solid understanding of financial and business principles including project budgeting, production cost estimation, and forecast planning.
• Advanced knowledge of product design, design for manufacturability, test methods, usability, and other aspects of design engineering.
• Track record of successfully leading and collaborating with multiple functions and teams to drive successful project outcomes.
• Energetic, self-motivated and can work independently, with a strong work ethic.
• Working knowledge of U.S. and international standards as applicable to medical device development.
• Proficient with Microsoft Outlook, Word, Excel, PowerPoint, and Teams.
• Familiarity with CAD software such as AutoCAD, Pro/E or SolidWorks.
• Able to travel to visit customers, manufacturing plants, and vendors (up to 15% time).
• Ability to achieve credentialing through healthcare vendor credentialing agencies, including being vaccinated against COVID-19.******