INGENYX - Product Development Engineer
Teleflex
Summary
The Product Development Engineer is responsible for the design and development of new products, for sustaining existing products, including design calculations, creating solid models, and detailing prints with minimal supervision, and for interfacing with customers, vendors, and internal departments, all of which are essential to achieving our goal of on-time delivery and high quality products.
Job description
Position Summary
The Product Development Engineer is responsible for the design and development of new products, for sustaining existing products, including design calculations, creating solid models, and detailing prints with minimal supervision, and for interfacing with customers, vendors, and internal departments, all of which are essential to achieving our goal of on-time delivery and high quality products.
Principal Responsibilities
- Lead the design and development of new products
- Participate in design reviews and technical feasibility assessments to ensure successful project execution and compliance with quality standards
- Review and approve requests for customer quotations for new product opportunities to ensure technical feasibility, manufacturability, and alignment with production capabilities
- Develop product cost estimates for new products by evaluating materials, labor, tooling and manufacturing processes
- Manage projects as a team leader, including scope, timelines, deliverables, risks, and resource coordination
- Lead the development, execution, and approval of product and process validation activities for new products, including test methods, fixtures, PFMEAs, Control Plans, IQ/OQ/PQ, Verification and Validation testing, and associated protocols and reports
- Define product specifications, performance requirements, tolerances, and manufacturing limitations
- Research new materials, assembly methods, and manufacturing processes
- Initiate, process, and review Engineering Change Notices
- Provide technical support to manufacturing, marketing, and customer service; interface with customers and suppliers
- Implement cost reduction by working closely with manufacturing to reduce scrap and waste
- Create detailed 3D models, assemblies, and engineering drawings using SolidWorks and associated CAD tools
- Perform engineering analyses to verify designs, including calculations, tolerance stack-ups, finite element analysis (FEA), and other simulation techniques as required
Education / Experience Requirements
- BS Mechanical Engineering, or the equivalent in a related field
- 3+ years' experience in manufacturing environment, preferably Medical Device manufacturing
- Experience with Plastics preferred
Specialized Skills / Other Requirements
- Proficient in 3D Modeling, preferably SolidWorks
- Good working knowledge of manufacturing processes related to medical device manufacturing
- Proficient in MS Office Products
- Excellent oral and written communication skills
- Ability to prioritize and work independently
- Ability to manage development programs across multiple locations and project teams
- Familiar with the design controls, FDA regulation, and GMP practices, QSR requirements
- Experience with Risk Analyst
- Relies heavily on experience and judgment to plan and accomplish goals
- Good working knowledge of GD&T
Requirements
- BS Mechanical Engineering, or the equivalent in a related field
- 3+ years' experience in manufacturing environment, preferably Medical Device manufacturing
- Experience with Plastics preferred
- Proficient in 3D Modeling, preferably SolidWorks
- Good working knowledge of manufacturing processes related to medical device manufacturing
- Proficient in MS Office Products
- Excellent oral and written communication skills
- Ability to prioritize and work independently
- Ability to manage development programs across multiple locations and project teams
- Familiar with the design controls, FDA regulation, and GMP practices, QSR requirements
- Experience with Risk Analyst
- Good working knowledge of GD&T
Company overview
Teleflex Incorporated is a global medical technology company headquartered in Wayne, Pennsylvania, that specializes in designing, developing, manufacturing, and supplying single-use medical devices for critical care and surgical applications. Founded in 1943, the company has evolved from its origins in precision mechanical controls to become a leading provider of innovative medical technologies. Teleflex serves healthcare providers in over 150 countries through a diverse portfolio that includes solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical procedures, vascular access, and urology. The company's well-known product brands include Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck. With approximately 14,000 employees worldwide, Teleflex operates 11 manufacturing facilities and 23 distribution centers across the globe. The company focuses on purpose-driven innovation to address unmet clinical needs, aiming to improve patient outcomes, enhance provider safety, and reduce procedural costs while maintaining a strong commitment to quality and corporate social responsibility.