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.

****Candidate would preferably live within 2 hours of Lincolnshire IL office. This position will work remotely but will require you to come to any of our sites and/or customer sites, as needed.

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 TIDI 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.