Sr R&D Engineer

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Support R&D team to design and test catheters and delivery systems
• Develop concepts, designs and details for machines, tools and fixtures.
• Support includes overall design, design for manufacturing, test method development, and product verification and validation testing
• Lead technical discussion and decision making with cross functional team.
• Interface between external vendors and core team.
• Develop specifications, engineering blueprints and detail drawings.
• Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Provide design changes for existing products. Ensures proper documentation of changes.
• Create engineering designs, develop plans and keep laboratory notebooks on all work.
• Conduct testing (Bench, V&V, in vivo); develop and utilize test protocols; generate written reports.
• Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

Performs other duties assigned as needed.

SUPERVISOR RESPONSIBILITIES:

The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.

Qualifications for Internal Candidates

QUALIFICATIONS:

• Bachelor’s Degree in Mechanical Engineering is required.
• Master's Degree in Mechanical or Biomedical Engineering is preferred.
• Must have five (5) plus years’ relevant Engineering experience
• Knowledge and experience in catheter design is required.
• Experience with CAD software such as AutoCad or Solidworks is required.
• Knowledge and experience in development processes and in documentation writing is required.
• Experience with statistical analysis and design of experiments (DOE) preferred.
• Ability to use PC and associated software is required.
• In-depth knowledge of material and metals is required.
• Knowledge of Good Manufacturing Process and Good Documentation Practice.

COMPENTENCIES:

To perform the job successfully, an individual should demonstrate the following competencies:

• Values: Integrity, Accountability, Teamwork, Innovation
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to manage tight timelines and changing priorities
• Excellent problem -solving techniques
• Proficient with Microsoft office applications
• Skilled at providing technical leadership on cross-functional teams