- The senior scientist will be responsible for performing materials assessments to support medical device project teams with submission activities related to material compliance to regulatory bodies through the Science and Technology Materials Group lab located in Little Canada, Minnesota at the Woodridge location.
- An understanding of EU MDR is strongly preferred.
- The candidate will have experience in analytical chemistry, partnering with clients, defining study plans, leading problem-solving initiatives.
- Additionally, candidate will have experience in a dynamic team environment and have strong interpersonal skills.
- Knowledge of medical devices is preferred. The candidate will have excellent organizational skills and be results oriented.
- The candidate will also have experience with documenting experiments in a highly regulated environment and knowledge of technical concepts and principles underlying Materials Science and supporting analytical techniques.
- Successful candidate will have substantial knowledge and technical expertise in materials used in medical devices including metallic and polymeric materials. This includes providing analytical assessment and consultation to support project teams to help meet their objectives.
- Substantial understanding of materials (and associated industry standards) used in biomedical applications such as CoCr alloys, titanium alloys, nickel alloys, stainless steels, PEEK, PTFE, thermoplastics.
- Materials used in long term implant applications and short-term applications (guidewires, delivery systems etc.)
- Includes processing and processing effects on materials
- Ability to write justifications with references for use within regulatory space
- Ability to strategize with testing when justifications are not appropriate
- Experience in protocol and report writing along with scientific data review
- Surface analysis
- Microscopy
- SEM/ESEM/EDS/WDS
- AES/XPS
- FIB
- Failure analysis
- Metals/plastics/composite
- Microscopy (optical, electron, confocal laser)
- Spectroscopy (EDS/FTIR/Raman)
- Metallography (embed, x-section-polish, etch, grain structure/size)
- Fractography
- CT
- Perform leaching study design, data collection and analysis (ASTM F3306, ISO10993)
- Operate and maintain GC/MS and ICP/MS systems
- Analyze data with multiple software platforms
- Ability to review, interpret and approve data
- SOP, Work Instruction and quality document writing
- Bachelor's degree, Master's degree, or PhD in material science or related degree; or equivalent work experience
- 5-10 years of experience and/or advanced education in materials science and engineering with focus on biomedical materials is required.
- experience in biomaterials (such as nitinol, stainless steel, titanium, carbon, polyurethanes, and others) and their interactions with biological systems
- Experience and understanding of cGMP, ISO 10993 part 18, FDA and ICH requirements
- Individual must communicate well with all levels of management and employees. Candidate must work well in collaborative environment across functional areas
- Ability to collaborate and work as a team player
- Ability to work and be effective with minimal supervision
- Strong verbal and written communication skills
- Ability to prioritize and execute on daily project tasks
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Description
Job Description
Job DescriptionSuccessful candidate will have knowledge and technical expertise in testing techniques in materials science:
Analytical chemistry
Qualifications:
