INGENYX - Product Development Engineer

Expected Travel : Up to 10%

Requisition ID : 14552

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.

Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

For more information, please visit Ingenyx.com

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, to ensure new products and processes meet customer, and quality requirements.
• 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.

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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.

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At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Ingenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: View phone number on aiapply.co or View email address on aiapply.co.