Biocompatibility Engineer - EUMDR (JM2025)

Techlink Systems

Mansfield, MA, USA

Published: 6/14/2022

Engineering

Full Time

Job Description

Job Title: Biocompatibility Engineer/Scientist III

Description:

Biocompatibility Senior Specialist/Engineer III

Must Have Skill :

Experience in the scope of Biocompatibility for products for EUMDR compliance
Experience in chemical characterization of materials
Knowledge of ISO 10993 series of standards
Design Biocompatibility testing strategy to provide efficient delivery of test results for BSI submissions
Provide Bio comp risk assessment report based on test results

Nice to have Skills :

Experience with BSI submissions for Biocompatibility
Experience working with Class III, class II and class I devices

Responsibilities:

Provide Biocompatibility assessment for Integra's vast majority of products falling into the category of Medical Devices, Define applicable Biocompatibility tests to evaluate product compliance to ISO10993 standard, Assure product biocompatibility to comply with EUMDR regulations, Work with outside laboratory on Biocompatibility test definitions and arrangements, Write final Biocompatibility assessment reports.

Qualifications:

BS or MS degree in Biology/Chemistry or equivalent is preferred, Min 5-year experience working in Medical Device industry is a must, Knowledge of ISO10993 is a must, Experience working with test laboratories for Biocompatibility product assessment, Experience working with product development engineering to identify appropriate representative of product families, Excellent writing and communication skills

Company DescriptionOverview

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

We also have national recruiting

Company Description

Overview\r\n\r\nTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. \r\n\r\nWe also have national recruiting