Acumed LLC
Come join a team where People make the difference!As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.
Job Scope
The Biocompatibility Specialist will enhance patient safety by supporting biological evaluations per ISO 10993 of orthopedic medical devices (Class I - III), collaborating with the biocompatibility team, Subject Matter Experts, and cross-functional teams to meet global regulatory standards.
Duties/Responsibilities
- Support development of biocompatibility risk assessment strategies for orthopedic medical devices (Class I – III).
- Author biological evaluation plans, test protocols, and reports in line with biological standards and international regulations.
- Review protocols, reports, and test data with external labs and experts.
- Analyze biocompatibility tests and chemical characterization data to ensure compliance.
- Coordinate biological safety testing and chemical characterization with CROs, ensuring proper execution.
- Troubleshoot unexpected test results and their impact on biocompatibility strategies.
- Support product development teams in assessing biological safety for new products.
- Collaborate and communicate with stakeholders to meet biocompatibility requirements.
- Conduct gap analysis on revised standards and regulatory guidance for biological safety.
- Develop internal procedures, work instructions, and SOPs to meet international regulatory requirements.
- Support and execute Corrective and Preventive Actions (CAPAs) for biological safety.
- Respond to regulatory queries regarding biological safety.
Qualifications
- Bachelor’s degree in Biology, Biomedical Engineering, Material Science, or related field with 1-3 years of medical device industry experience; Master’s degree preferred.
- Fundamental understanding and experience with ISO 10993 standards, medical device manufacturing, and biocompatibility assessment.
- Preferred experience managing biological safety studies at CROs within the GLP framework.
- Strong technical writing skills.
- Effective communication across all levels and departments (e.g., Quality, Regulatory).
- Ability to multitask and align priorities with biocompatibility program objectives.
- Demonstrates critical thinking, problem-solving, data analysis, and presentation skills.
- Self-motivated and proactive with minimal supervision.
- Proficiency with MS Word, Excel, and other office tools.
- Familiarity with engineering systems like SAP, Windchill, and CAD software preferred.
Target Compensation: $86,524.76 – $105,752.48
Benefits: Medical, Dental, and Vision insurance, 401k matching, + more.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.