Remote role
BioCompatibility Experience
Fundamental understanding or direct experience of the ISO 10993 standards, ISO 10993 biocompatibility materials and process risk assessment, biomaterials, toxicological assessment, extractable and leachable analysis, and medical device manufacturing processes
Top Skills
- Biocompatibility exp is a must have
- ISO 10993 (manager will ask a lot of questions about 10993 standards)
- Local candidates preferred but willing to consider remote for right fit
Description
- Primarily reviewing older data and putting it together and then writing reports
- Can work 40-45 hours per week depending on work load
- Interview: phone and then video
- Education: 4 yr degree plus 2 plus yrs. experience
- Current biocompatibility experience is a plus
- Self-motivated
- Present all finds to strategy team
- Lot of reviewing older data
- Find people that have MDR submission experience
- Current experience is a huge advantage
- Document control system (windchill) experience is a plus
- Organized and self-driven
- Request information
- Client can provide training material but candidate should be self-motivated
- Associates degree will work with 5 yrs. of experience
- There is an opportunity for contract to hire
- Not looking for a toxicologist
- Risk assessment experience needed
Qualifications
- BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Chemistry, Materials Science, or Toxicology. Extensive relevant job experience will be considered and can satisfy degree requirements
- 4-6 years’ industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation
- Demonstrated ability to draw risked based conclusions, present and make recommendations based on technical inputs from multiple and varied functions
- Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels
- Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit
- Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables
- Must possess strong analytical and process skills, and be computer proficient in Excel, MS Project, PowerPoint, Word
Job Types: Full-time, Contract
Pay: $70.00 – $78.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Education:
- Bachelor’s (Preferred)
Experience:
- BioCompatibility: 4 years (Preferred)
- ISO 10993: 4 years (Preferred)
- MDR submission: 4 years (Preferred)
Contract Length:
- 5 – 6 months
Work Location:
- Fully Remote
Source: Indeed.com
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