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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing and validating antithrombotic coating processes while ensuring compliance with regulatory standards such as ISO 13485 and FDA. Proficient in leading project teams and driving continuous improvement in manufacturing processes for medical devices.
Highest-signal resume keywords
Master Of Science Degree In EngineeringSurface Chemistry ExpertiseMedical Device ExperienceProcess Validation Knowledge (IQ/OQ/PQ)Fluency In French And English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Antithrombotic Coating Process ManagementManufacturing Process DesignAnalytical Techniques (XPS, TOF-SIMS, Infrared Spectroscopy)Process Statistical Data AnalysisRegulatory Compliance Knowledge
Soft Skills
Project Monitoring And ManagementTeam CoordinationCommunication Skills
Tools & Technologies
Microsoft Office (Excel, Word, PowerPoint)
Industry Keywords
ISO 13485FDAMDRDevice Master Record (DMR)Continuous Improvement
Tech Stack
Tools & technologiesTypeScript
About the role
Key responsibilities & impact- Manage and validate the antithrombotic coating process
- Transform R&D concepts into robust, reliable industrial processes that comply with regulatory and quality requirements (ISO 13485, FDA, MDR)
- Define, implement, and validate the required production capabilities, including equipment and processes
- Lead production capabilities and drive continuous improvement to ensure industrial performance in terms of quality, cost, and delivery
- Coordinate a project team of 3 to 4 team members
- Transfer the design into manufacturing process specifications
- Design the manufacturing process
- Characterize the process
- Ensure that test methods are validated
- Lead and execute process validation
- Establish process compliance monitoring
- Lead the preparation of documents associated with the Device Master Record (DMR)
Requirements
What you’ll need- Master of Science degree or higher in an engineering discipline, such as chemical, mechanical, biomedical, industrial engineering, or a related field
- Strong expertise in surface chemistry and materials chemistry
- Experience in medical devices
- Proficiency in Microsoft Office (Excel, Word, PowerPoint, etc.)
- Project monitoring and management skills, including tasks, resources, timelines, and budgets
- Fluency in French and English, essential for internal and external communication
- Coating expertise
- Proficiency in analytical techniques such as XPS, TOF-SIMS, and infrared spectroscopy
- Knowledge and application of key process validation stages (IQ/OQ/PQ)
- Ability to generate and analyze process statistical data
- Knowledge of standards and requirements associated with manufacturing processes
- Ability to identify and communicate product improvements
Benefits
Comp & perks- Inclusive, diverse, equitable, and supportive work environment
- Professional development opportunities
- Varied, high-value projects
- Collaboration with recognized experts
- Opportunity to contribute to improving the patient journey
- Equal opportunity
- Shared mission in the healthcare sector