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Teleflex · 13 hours ago

Engineer 2, Product Development, R&D

Wyomissing PA USA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Teleflex is a global provider of medical technologies dedicated to improving health and quality of life. The Project Engineer – Design Development will apply engineering principles to create innovative vascular access products, ensuring they meet clinical needs and regulatory standards while collaborating cross-functionally.

Medical DeviceHealthcareCommercialHealth CareMedical

H1B Sponsor Likely

Responsibilities

Independently create and refine CAD models for product and fixture design using standard modeling tools

Conduct simulations and calculations to support design performance and heat transfer assessments

Apply DFM and tolerance analysis to ensure part fit and ergonomic product interaction

Design simple test fixtures and tooling using HFUE principles

Execute patent searches to identify conflicts and guide unique product solutions

Utilize DFMEA to identify and mitigate design risks early in development

Draft comprehensive and traceable design documentation and test rationales

Translate user needs into clear, testable design inputs using UFMEA and task analysis

Participate in formative evaluations and plan for design validation activities

Develop test methods aligned with design verification strategies

Perform design verification activities and analyze test outcomes for conformance

Prepare phase-specific development plans and maintain updated D&D documentation

Generate and manage essential design outputs, including drawings and assembly instructions

Ensure compliance with ISO and FDA design control standards during development

Provide support during design reviews to align design work with regulatory requirements

Qualification

CAD modelingDFM analysisDFMEAMedical device developmentHeat transfer assessmentTest method developmentISO complianceDesign documentationRegulatory requirementsCross-functional collaboration

Required

Bachelor's degree in Mechanical, Biomedical, or related Engineering field

2–4 years of experience in medical device product development, preferably in vascular access

Candidates without a technical degree require 6+ years of equivalent industry experience in medical device development