· 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.

Job Type: Contract

Pay: $70.00 - $75.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Brooklyn Park, MN 55445: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Research: 1 year (Preferred)

License/Certification:

• Licensed Pharmacist (Preferred)

Work Location: In person

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