- Engineering lead in OUS submissions (Europe and Asia) and optimizing more complex issues, including new technologies or processes pertinent to medical device design and manufacturing.
- Develop and execute novel processes, test methods, parts, components, subsystems, products, or complete systems. This includes establishing design requirements, generating design concepts and prototypes, manufacturing process controls, experimental testing, data analysis, and/or conducting pre-clinical evaluations.
- Establish product and system specifications to satisfy clinically relevant requirements.
- Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity.
- Generate and evaluate pertinent intellectual property.
- Supervise and/or mentor engineers, technicians and specialists.
- Largely self-directed, capable of meeting project goals with minimal supervision.
- Evaluates the biocompatibility test outcomes to ascertain whether the data sufficiently meets the criteria for biological effects and employs technical expertise and analytical skills to address any unforeseen results.
- Assists in addressing regulatory inquiries pertaining to past biocompatibility reports to facilitate domestic and international registrations.
- Directs testing activities with current and new suppliers; identifies 2nd source suppliers for biocompatibility and other related testing of new products.
- Other duties as assigned.
- BS engineering degree with 8+ years of related experience, or;
- MS engineering degree with 7+ year of related experience, or;
- Ph.D. in engineering with 3+ years of related experience.
- Excellent written and verbal communication skills.
- Apply fundamental and advanced engineering principles, concepts and techniques to solve complex problems related to product development.
- Expert knowledge of design controls for medical devices.
- Working knowledge of standard machine shop equipment and processes.
- Expert in one or more subject areas related to medical device design and manufacturing.
- Ability to lead internal and external technical discussions to achieve project goals.
- Exemplifies discretion and good decision-making skills.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management.
- Computer skills including Microsoft Office, Project etc.
- CAD proficiency (Solidworks preferred).
- Experience with development through commercialization process of medical devices.
- Experience participating and presenting at meetings with internal and external representatives.
- Catheter or peripheral system experience.
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Description
Support and lead cross functional teams in the design and development of novel medical devices and manufacturing processes. This includes being a primary contributor to both product and process development of new technologies used for device concepts.
Responsibilities
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.
