4 Biocompatibility Test Engineer Jobs in Manchester, NH
DEKA Research and Development is Hiring a Biocompatibility Test Engineer Near Manchester, NH
- 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
- 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.
Job Summary
Full Time
Scientific Services
$95k-109k (estimate)
03/15/2024
06/11/2024
dekaresearch.com
MANCHESTER, NH
500 - 1,000
1982
DEAN KAMEN
$50M - $200M
Scientific Services
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About DEKA Research and Development
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, design...ers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. Its a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
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