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Role: Biocompatibility specialist (Day one onsite)
Location: Brooklyn Park, MN
Job Type: Contract
Job description:
Minimum of 7+ years in medical device or pharmaceutical industry in R&D Engineering
BS or MS in Mechanical Engineering or equivalent with 7+ years progressive mechanical design experience in a regulated medical industry
Must to have: OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia
Adds Value:European Medical Device Regulation
Competency as a subject matter expert in the biocompatibility domain.
Has a comprehensive record of external training in the area of competence.
Has proven competency in presenting the subject matter to expert groups and key opinion leaders clearly and convincingly.
Relevant technical knowledge in biocompatibility/toxicology and an overall understanding of the material, physical and chemical properties
Ability to understand and apply global regulatory guidelines, including OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia, and regional compendia, European Medical Device Regulation
Experience writing and reviewing biological evaluations for new products and remediating existing ones
Fundamental understanding of toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, biocompatibility assessment methodology, and biocompatibility endpoint testing methodology
Knowledge of the risk assessment paradigm (i.e., hazard identification, exposure assessment, dose-response assessment, and risk characterization).
Ability to recognize how to best interpret, summarize, and present information to ensure quality and accuracy of content in complex document types under general supervision.
Ability to understand the functionality/intended use of complex devices.
Ability to work across various domains - planning & prioritizing, tracking monthly matrices, and creating dashboards.
Proficiency in Microsoft Office Suite (Word, Excel, Teams, and PowerPoint). Other preferred software: SharePoint and DocuSign
Has experience in conveying complex scientific topics in a clear and comprehensible fashion. Strong problem-solving skills..
Biocompatibility assessment and organization of respective testing for medical devices.
Supporting resolution of biological evaluation issues for current manufacturing facilities and new product development.
Internal technical document creation and approval.
Supporting Complaints investigations, corrective action and preventive actions, and other general technical support duties required within the team.
Creating Technical Reviews, specifications, and other mandatory documents for regulatory submissions.
Reviewing and preparing procedures to keep pace with standards development.
Representing the company via presentations to groups of experts, societies, and regulatory bodies and at international meetings.
Helping develop and generate material for staff training and data presentations.
Maintaining relevant scientific and medical knowledge by attending conferences, courses, and meetings.
Educating internal colleagues across departments and divisions in the area of biological safety evaluations, risk assessments, and chemical characterization.
Providing support for key opinion leaders.
Ensure compliance with the client's and internal training, Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant guidelines
Demonstrates ability to balance the needs of all departments to meet customer expectations and project schedules.
Demonstrates an ability to utilize resources efficiently.
Demonstrated ability to represent the company to accomplish objectives even during disagreements.
Is professional, concise, and sensitive in accomplishing objectives.
Can diplomatically negotiate with a requester regarding what they want in design, process, scope, or timetable.
Has the ability to tailor the information to the audience and answer with confidence and authority scientific questions.
Participates in Audits and Inspections as required Handles discussions of complex topics with confidence.
Demonstrates ability to discuss sensitive information with and tailor communication style to listeners' perspectives, including management, surgeons, and external contacts.
Sanjay Singh
Delivery Manager
O: +1 217 374 4070
Email: sanjay.singh@trioptus.com | Web: (link removed)
United States | Canada | India
Trioptus
