Senior Engineer, R&D

Our Sr Engineer, R&D is instrumental in working towards our purpose every day!!

The Senior Engineer, R&D is responsible for product development within TIDI Products. 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 be required to come into any of our sites and/or customer sites, as needed.

• 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 team work via plans, communication, and records
• Follow 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.
• Performs other tasks, as required or directed.

• Understands internal and external customers
• Assures a safe work environment
• Encourages individual development
• Demonstrates teamwork and flexibility/adaptability
• Demonstrates honesty
• Keeps our commitments
• Thinks systemically and ensures constancy of purpose
• Leads with humility and respects every individual
• Focuses on process, embraces scientific thinking, flow and pull value, assures quality at the source and seeks perfection

• BS Engineering Degree (Mechanical, Biomedical, or Material‑Science preferred).
• At least 5-8 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.
• 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.
• Experience with user centered design principles, tools and techniques and usability engineering.
• Proven ability to analyze, synthesize, and summarize complex data about customer needs.
• Creative and resourceful at solving problems.
• Demonstrated ability to construct prototypes and concept models.
• Basic understanding of financial and business principles including project budgeting, production cost estimation, and forecast planning.
• Track record of successfully leading and collaborating with multiple functions and teams to drive successful project outcomes.
• Energetic, self‑motivated and can work independently; 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 Solid Works.
• Able to travel to visit customers, manufacturing plants, and vendors (up to 15% time).
• Ability to achieve credentialing through healthcare vendor credentialing…