This listing was posted on The Resumator.
Biocompatibility Test Engineer
Location:
Manchester, NH
Description:
We are seeking a Biocompatibility Test Engineer to join our growing team of dedicated technologists. This position will play a key role in supporting DEKA’s biocompatibility/sterility process across many projects, working with project cross-functional teams to provide biocompatibility, sterilization and other design safety deliverables in compliance with ISO 10993 and other regulatory guidelines. How you will make an impact: As a Biocompatibility Test Engineer you will focus on the biocompatibility and toxicological evaluation of designs required for approvals and patient safety Working with team members and stakeholders, you will design and implement effective biocompatibility and sterilization testing strategies, plans and test procedures in accordance with FDA requirements, internal SOPs and standards Coordinate and facilitate testing related to sterile barrier integrity (packaging), sterilization validation, endotoxin, toxicology, drug stability and compatibility, particulate, and reprocessing validations Liaise with internal resources (engineering, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing Review test results to ensure design requirements are met Utilize problem solving skills and technical knowledge to troubleshoot testing anomalies Coordinate toxicological risk assessments with toxicologists for a variety of medical devices across the company Evaluate new designs and changes in design per organizational risk management practices to ensure effective, safe and compliant devices Manage multiple projects requiring biocompatibility and sterilization evaluations ensuring timely completion of required tasks to meet project schedules Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of this knowledge in others Support Regulatory Affairs on preparing information related to FDA-related correspondences To succeed in this role, you will need the following skills and experience: Bachelor’s degree in an engineering or scientific discipline such as Biomedical Engineering, Biology, Biochemistry, Chemistry, or Microbiology 1-3 years of experience in the medical device industry Attention to detail necessary to maintain the required documentation Excellent technical writing, verbal communication, and organizational skills Experience writing and reviewing test procedures and reports Good interpersonal skills and demonstrated success working in a collaborative environment Ability to work independently with minimal supervision Experience with using good laboratory practices (GLP) About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.Powered by JazzHR
Company:
Deka Research & Development
Posted:
March 13 on The Resumator
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to The Resumator
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Biocompatibility Test Engineer
Biocompatibility Test Engineer is a Engineering Test Engineer Job at Deka Research & Development located in Manchester NH. Find other listings like Biocompatibility Test Engineer by searching Oodle for Engineering Test Engineer Jobs.
Biocompatibility Test Engineer is a Engineering Test Engineer Job at Deka Research & Development located in Manchester NH. Find other listings like Biocompatibility Test Engineer by searching Oodle for Engineering Test Engineer Jobs.