DEVICE DEVELOPMENT ENGINEER

 

 

Device Development Engineer

(38-06)

 

Note:  RenaMed Biologics is currently located in Lincoln, RI (02865).  We are in the process of moving to our new Westborough, MA (01581) facility.  This position will report to the Lincoln, RI facility initially, and to the Wesborough, MA facility ultimately.

 

 

JOB OVERVIEW

 

This individual will be a member of a team which will support the development of an adjunct extracorporeal blood pumping system to be used with continuous veno-venous hemofiltration (CVVH) equipment in acute renal failure, supportive to the Renal Assist Device (RAD), and ancillary sterile disposable tubing set. 

 

RESPONSIBILITIES

 

The selected individual will evaluate mechanical and electro-mechanical materials, components, assemblies, processes and or equipment.  They will conduct feasibility studies to verify capability and functionality. They will evaluate new concepts from initial design to market release.  They will provide the working, technical knowledge and application of concepts, practices and procedures associated with sterile extracorporeal circuits and sterile disposable tubing sets.  They will perform this job in a quality system environment and participate in design control and associated documentation activities.  Failure to adequately perform tasks can result in noncompliance with governmental regulations


This individual will be responsible for providing engineering support in the set up of clinical sites, qualification of equipment ancillary to the CVVH equipment.  They will also troubleshoot as needed for the clinical set up and use of same.  They will define, coordinate and document set up, support, equipment qualification, and PM.  They will also respond to complaints associated with equipment malfunction or performance and will provide support to resolve investigations to determine root cause of failures.  They will be responsible for establishing corrective and preventive actions as a result.

 

Additional responsibilities will also include supplier selection, assessment, and development of acceptance criteria and evaluation of supplier capabilities.  This individual may interface with suppliers and cross functional personnel to successfully support electro-mechanical device development and the sterile tubing sets used with the Renal Assist Device connected to the CRRT and RAD circuits.  This position requires some travel to suppliers and clinical sites, and cross functional assignment to development group.  The position is one of a team of four to be put in place during 2006.

 

 

JOB REQUIREMENTS

 

BS/MS in biomedical, industrial or mechanical engineering discipline is required 2+ years with a BS or 0-3  years with an MS of relevant industrial experience.

 

Some relative experience where applied in the following areas:

 Experience in creating cross-functional FMEAs, risk analyses, or other hazard analyses required.

 Experience in executing design verification and validation protocols required.

 Experience in working with outside facilities to perform contract mechanical testing is desired.

 Experience with sterile, extracorporeal blood pumping systems is required, and specific experience with renal replacement therapies (dialysis, CVVH) is a plus.

 Working experience within design control is required.  

 Sterilization (gamma, EtO) experience is desired. 

 Plastics engineering experience a plus. 

 Component engineering, manufacturing and process development experience strongly desired.  

 Experience with generating and implementing technology testing and evaluation plans strongly preferred.

 

 

 

 

RenaMed Biologics is an Equal Opportunity Employer

 

RenaMed Biologics, Inc. is a biotechnology company focused on the development and commercialization of therapies for the treatment of diseases associated with compromised kidney function. RenaMed?s products are designed to dramatically improve the clinical outcome and cost of care for patients suffering from Acute Renal Failure and additional indications where kidney function is compromised.

 

 

For more information visit our website:  www.renamedbio.com