Home > San Diego jobs > San Diego trades & labor jobs

Posted: Tuesday, March 6, 2018 10:29 AM

Job Description
Assist in the development of Design Verification and Process Validation documentation such as protocols and reports, executes qualifications, and performs statistical analysis as required to ensure QST compliance of product and process development.
Help maintain manufacturing documentation (drawings, material specifications, inspection procedures, labels and manufacturing instructions).
Performs equipment maintenance activities and maintains updated records.
Provide engineering support with Quality activities including, but not limited to, NCRs, CAPAs and complaint handling.
Provide engineering support with Manufacturing activities including, but not limited to, resolution of production issues, supplier issues, etc.
Provide general engineering support in design and development of safe and effective medical device products.
Interact with other pfm medical companies in the resolution of engineering issues and improvements to products distributed by pfm medical, Inc. on their behalf.
Work in a cross:functional team.
Understand and use the Change Control procedure for internal and external documentation.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
BS in an Engineering discipline applicable to medical devices and/or biotechnology.
1:3 years of experience.
Proficient with Microsoft Office, including Word, Excel and PowerPoint.
Proficient with Solidworks.
Good written and oral communication skills.
In depth knowledge of US FDA Title 21 CFR Part 820, ISO 13485 and cGMP.
Proficient with Minitab.
Proficient with Microsoft Project.
Previous experience working for a medical device, biotechnology or pharmaceutical company.
JOB TYPE: Full:time
*Relocation assistance is not available for this position.*
Company Description
pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities. In addition, the company was founded to conduct clinical research and studies in the United States. pfm medical Inc. is located in Carlsbad, California and is well positioned to support its distributor network with on time shipments and quality customer service.


• Location: San Diego

• Post ID: 37194782 sandiego is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018