INGENYX - Product Development Engineer

Teleflex•Jaffrey, NH

About The Position

The Product Development Engineer designs and develops new products and sustains existing products. The role includes performing design calculations, creating solid models, detailing prints with minimal supervision, and interfacing with customers, vendors, and internal departments to support on-time delivery and high-quality products. The engineer leads product development and validation activities, manages project scope and execution, supports manufacturing and other internal functions, and helps ensure designs meet customer, manufacturing, and quality requirements. The position also contributes to product cost estimation, process improvement, and cost reduction.

Requirements

Bachelor of Science in Mechanical Engineering or an equivalent degree in a related field.
At least 3 years of experience in a manufacturing environment.
Proficiency in 3D modeling; SolidWorks is preferred.
Good working knowledge of manufacturing processes related to medical device manufacturing.
Proficiency in Microsoft Office products.
Excellent oral and written communication skills.
Ability to prioritize work and work independently.
Ability to manage development programs across multiple locations and project teams.
Familiarity with design controls, FDA regulations, GMP practices, and QSR requirements.
Experience with Risk Analyst.
Good working knowledge of GD&T.

Nice To Haves

Experience in medical device manufacturing.
Experience with plastics.
Proficiency in SolidWorks.

Responsibilities

Lead the design and development of new products.
Participate in design reviews and technical feasibility assessments to support successful project execution and compliance with quality standards.
Review and approve customer quotation requests for new product opportunities, assessing technical feasibility, manufacturability, and alignment with production capabilities.
Develop product cost estimates 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, 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, and interface with customers and suppliers.
Implement cost reductions by working 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, and other simulation techniques as required.