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Senior Project 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!

JOB DESCRIPTION

Working under general supervision, supports and leads the product development efforts by performing key research, product development and engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of specific projects. Performs additional analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study.

This person demonstrates aspects of technical or organizational leadership within the current projects. Has the ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises appropriate level of technical judgment in planning, organizing, performing and coordinating clinical-systems engineering assignments. Stays abreast of and communicates technical advancements to colleagues and associates. Routinely uses the most effective, cost efficient and best practices to execute processes.



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 leading development projects as the leader and manager of the project.

* Practical and working knowledge of medical grade and implantable materials.

* Understanding of biomechanics and able to collaborate with clinicians, bioengineers and scientists to characterize physiologic and mechanical function of medical devices.

* 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 LMJ is in compliance with Regulations (e.g., QSR, CMDR and MDD), Standards (e.g., ISO 13485) and the Quality Management System Manual

* Assist Product Development, Marketing and Operations personnel and General Management by:

Identifying, applying and instituting applicable standards, guidance documents, and regulatory requirements in the assessment, characterization and testing of products and applied materials.

Collaborating with internal partners, 3rd party laboratories and national and international regulatory bodies in establishing safety profiles for implantable medical devices.

Developing reports for national and international regulatory bodies, internal management as well as establishing data to support the product and product development effort.

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

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 performance 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.

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

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:

Maintaining professionalism and integrity in all aspects of internal and external interactions.

Leading, managing and participating in product development teams.

Establishing, maintaining and participating in key material councils (such as ASTM) and committees representing LMJ.

Working well with other employees and convey positive attitude.

Keywords: LoveMyJob, Philadelphia, Senior Project Engineer, Engineering, Cheyney, Pennsylvania

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