SUMMARY: Develops and completes designs for minimally invasive surgical instruments. Initiates, Plans, Directs Execution and brings to conclusion projects in the R&D portfolio. Leads design reviews with engineering, operations, and other stakeholders to reconcile objectives. Analyzes complex problems independently and initiates appropriate corrective actions. This position requires a deep understanding of Microline's products being able to make decisions that will have direct impact on the quality of our products.
ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
- Research and analyze data such as customer requirements, standards and industry trends to determine feasibility of design or application.
- Interface with health care professionals to define customer requirements.
- Provide alternative product designs and evaluate them using various analytical tools like tolerance analysis, design for manufacturability and assembly, etc.
- Follow Design Controls and GMP regulations.
- Create and maintain Design History File and traceability among its different elements like Requirements, Risk, V&V documents.
- Understand IEC, ISO standards that apply to Microline's products
- Create drawings and layouts of new or improved designs for prototype fabrication.
- Effectively communicate information to co-workers, customers and suppliers in order to facilitate project goals.
- Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and corporate guidelines.
- Serve as project team leader throughout the new product development process; identify critical technical challenges, define schedules, assign tasks and quantify progress against project goals.
- Accurately predict the time required for project tasks; help assure the scheduled time is met or improved to meet company objectives. Timely communicate risks or issues that may affect the project quality, cost or schedule.
NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.
- BS degree in engineering or equivalent experience.
- Mechanical Engineering background with working knowledge of electronics / software.
- Minimum of 5+ years of related experience in the medical device industry
- Strong written and verbal communication skills for the purpose of technical/mechanical comprehension. Must be able to effectively communicate with medical professionals, outside contractors, customers and vendors.
- Proficient in the use of Solidworks / PDM Vault
- Must have demonstrated ability to work as part of a team.
- Demonstrated complex problem-solving skills using structured problem solving methodologies.
- Must be able to work independently and be self-motivated.
- Strong Program/Project management skills needed.
REASONABLE ACCOMMODATION: Microline Surgical is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.
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