Sr. Project Engineer

Piper Companies; Lower Providence Township (PA); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

A medical device manufacturer is seeking a skilled Sr. Project Engineer in Audubon, Pennsylvania. The role includes designing surgical implants and medical devices while ensuring compliance with FDA guidelines. Candidates should have at least 5 years of related experience and strong proficiency in CREO or similar CAD software. The position offers a competitive salary between $110,000 and $120,000 based on experience, along with a comprehensive benefits package.

Qualifications

• Minimum of 5 years’ experience with the development of medical devices or similar products.
• Strong experience working with CREO or similar CAD software.
• Experience preparing regulatory documentation in accordance with FDA medical device guidelines.

Responsibilities

• Assist in the development and design of surgical implants and medical devices.
• Participate in prototyping, fabrication, and 3D printing of product design.
• Ensure designs comply with FDA medical device guidelines.
• Maintain project plans and FDA compliant Design History Files (DHF).
• Conduct in-depth analysis of performance, safety, and design.

Skills

Development of medical devices

CREO or similar CAD software

Preparing regulatory documentation

3D printing of product design

Education

B.S. in Engineering or related field

Tools

CREO

FEA Software

Job description

Overview

Piper Companies is currently looking for an experienced Sr. Project Engineer in Audubon, Pennsylvania (PA) to work for an innovative and growing medical device manufacturer. The Product Development Engineer will play a significant role in the design of medical devices.

Responsibilities

• Assist in the development and design of surgical implants and medical devices
• Participate in prototyping, fabrication, and 3D printing of product design
• Ensuring designs coincide with FDA medical device guidelines
• Creating and maintaining project plans and FDA compliant Design History Files (DHF) for each project
• Conducting in depth analysis of the performance, safety, and design of future products

Qualifications

• A minimum of 5 years’ experience with the development of medical devices or similar products
• Strong experience working with CREO or similar CAD software
• Experience preparing regulatory documentation in accordance with FDA medical device guidelines
• B.S. in Engineering or related field required

Compensation

• Salary Range is $110,000 - $120,000 dependent upon experience
• Comprehensive benefits package

Keywords

Sr. Project Engineer, Product Development Engineer, Development Engineer, Mechanical Design Engineer, greater Philadelphia area, Pennsylvania, PA, Audubon, FDA, medical device, surgical, class 3, Class III, design, development, ACCME, validation, ISO 134851, Creo, ProEngineer Software, FEA Software, CFR 21 820.30, drafting, manufacturing, GD&T, CAD, research, Science, comprehensive benefits package, Health, Vision, Dental.

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