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Product Development Engineer

Company: LoveMyJob
Location: Cheyney
Posted on: December 2, 2017

Job Description:

Our Client is a leader in orthopedic implants and has been recognized as one of the most innovative Engineering and Design Organizations in the country. With 30 years of experience and over 50,000 implants, through strategic mergers & acquisitions and innovative patent designs, it's no wonder their work growth is limitless.

Their culture strikes an equal balance of stability and reputation, with growth, innovation, and entrepreneurship. If you like large complex matrix environments with slow and steadycareer path and professional development, this role is not for you. Like most growing organizations you will receive more responsibility and accountability for your role while gaining experience and professional development at the speed in which you can keep up.

Their collective passion for their products, patients, and impact is why their people drive their culture and work as hard as they do!

APPLICABLE DOCUMENTS

* SOP 6-01 SOP, Training & Job descriptions.

* QMSM Quality management system manual.

* Regulations & Standards.

EDUCATION REQUIREMENTS

* B.S. Engineering required.

EXPERIENCE REQUIREMENTS

* Mechanical design, bio-mechanics and anatomy desired.

* Experience in design and development of medical devices and associated components using SolidWorks and PDM/CAE tools is desired.

JOB REQUIREMENTS

* Must work to ensure that we are in compliance with Regulations (e.g., QSR, CMDR and MDD), Standards (e.g., ISO 13485) and the Quality Management System Manual

* Assist engineering personnel and engineering management by:

Designing and formulating modifications of existing products and developing and implementing practical and innovative designs for new products and medical devices.

Developing reports for engineering management designed to keep track of the status of the implementation of product design plans.

Maintaining post-marketing surveillance files and updated information on project compliance with national and international standards governing the spinal implant field.

Working closely with surgeon advisors and marketing personnel with the objective of identifying potential innovations that can be achieved through the modification of existing products or the development of new product designs.

Testing and evaluating the efficacy of current product modifications and new products, including formulating feasibility studies on current and new products and studies and cadaver labs designed to evaluate levels of effectiveness.

Devising and implementing quality control procedures and validation protocols that govern the testing of product design models at each level of development through to release.

Reviewing and writing test reports associated with design feasibility, verification, and validation activities.

Working with sales personnel to assure that they understand the specifications and purposes of our products.

Assist Quality as required in complaint investigations and other quality management system/regulatory requirements.

Maintain design history files (DHFs) and assist quality with engineering elements of document control and work within the document control system. Perform new and revised document release reviews as part of document change notice system.

* Responsible for:

Performing inspection and testing including incoming inspection of prototypes and first batch finished goods and raw materials. Also responsible for maintaining inspection documentation on prototypes and first batch.

Working well with other employees and convey positive attitude.

Having professional appearance especially when representing the company off site e.g. interacting with surgeons.

Keywords: LoveMyJob, Philadelphia, Product Development Engineer, Engineering, Cheyney, Pennsylvania

Click here to apply!

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