Product Development Engineer

• Industry Medical Device , Manufacturing , Sales & Marketing
• Employee Type Exempt Full Time
• Required Degree 4 Year Degree
• Travel 5%

This position can work remotely, but must be within 3 hours of Neenah, WI AND Lincolnshire, IL.

The Product Development Engineer is responsible for product development within TIDI Products. Working closely with cross‑functional team members, the individual will lead projects to deliver new products, line extensions, and product improvements.

• Serves as project leader, technical leader, or team member for projects including new product development, line extensions, and product improvements.
• Collaborates with product development and cross‑functional team to develop timelines and project plans.
• Interfaces with customers (marketing, end user customers and OEM customers) to translate user needs into design requirements and validate designs.
• Uses engineering, analytical, and technical skills to design products to meet requirements.
• Develops and utilizes test methods and plans to evaluate product characteristics and performance.
• Creates, revises, and collaborates on project documents, protocols, drawings, and documentation to applicable internal and external standards.
• Collaborates with manufacturing team to transfer designs, develop manufacturing processes and documentation, and begin production.
• Engages outside design firms, testing labs and technical consultants to apply specialized expertise to projects.
• Leads engineering change controls to create and configure products within the TIDI Quality Management System.
• Identify and create standard work for new processes.
• Balance multiple projects, check and adjust on priorities, and adjust work appropriately.
• Uses basic knowledge of FDA and ISO Design Controls, Risk Management, and Design Transfer to follow TIDI procedures in accordance with regulations and complete all necessary documentation.
• Performs other tasks, as required or directed.

• Understands internal and external customers
• Assure a safe work environment
• Encourage individual development
• Demonstrates teamwork and flexibility/adaptability
• Demonstrates honesty
• Keep our commitments
• Think systemically and ensure constancy of purpose
• Lead with humility and respect every individual
• Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection

• BS Engineering Degree (Mechanical, Biomedical, Material‑Science, or Manufacturing preferred).
• At least 3 years experience 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.
• Track record of successfully collaborating with multiple functions and teams to drive successful project outcomes.
• Strong project management skills.
• 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.
• Proficient with CAD software such as AutoCAD, Pro/E or Solid Works.
• Able to travel to visit customers, manufacturing plants, and vendors (up to 10% time).

At TIDI Products we are committed to offering a comprehensive employee benefits program that helps our employees stay healthy, feel secure and maintain a work/life balance.

TIDI Products is a market leading manufacturing of disposable infection prevention products and patient safety products, headquartered in Neenah, WI. We have manufacturing and distribution facilities in Neenah, WI and Tijuana, MX. And office space in Lincolnshire, IL. TIDI provides best‑in‑class products and service to major healthcare distributors and users worldwide.

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