Employer Industry: Medical Device Manufacturing

Why Consider this Job Opportunity:
- Salary up to $156,900.00 plus bonus eligible
- Opportunity for career advancement and growth within the organization
- Remote work flexibility
- Chance to work with state-of-the-art products and processes
- Collaborative and cross-functional work environment
- Opportunity to develop and optimize work processes

What to Expect (Job Responsibilities):
- Plan and evaluate biocompatibility studies and special process validations for medical devices
- Review and apply internal and external guidance documents related to cleanliness and biological safety
- Develop protocols, reports, and regulatory summaries in collaboration with business partners and suppliers
- Analyze materials, design, suppliers, and processes to achieve optimal solutions for biological safety
- Lead project planning, risk analysis, and represent biocompatibility on new product development teams

What is Required (Qualifications):
- Bachelor's Degree in Biology, Microbiology, Science, Engineering, or a closely related field
- 2+ years of experience in the medical device industry or working in a lab
- Knowledge of relevant ISO 10993 series and country-specific regulations
- Understanding of sterilization, cleaning, packaging, and biocompatibility processes
- Strong analytical and process skills

How to Stand Out (Preferred Qualifications):
- Experience in biological evaluation of medical devices per ISO 10993
- Knowledge of manufacturing contaminants and establishing residual limits
- Proficiency in Excel, MS Teams, PowerPoint, Word, SharePoint, etc.
- Excellent communication and interpersonal skills
- Ability to work well with diverse cross-functional teams

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