Sr R&D Engineer

San JoseOn-siteFull-time$151k–$189k

AI Summary

Designs, tests and documents catheters and delivery systems for medical devices under FDA QSR and ISO 13485 requirements, leading cross-functional technical decisions and vendor interfaces. Also supervises and manages engineering staff.

About this role

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).

Qualifications

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

Pay range is $151,000-$189,000

Responsibilities

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.

Skills

AutoCADBench TestingCatheter DesignDesign For ManufacturingDesign Of ExperimentsFDA QSR 21 CFR 820Good Documentation PracticeGood Manufacturing PracticeISO 13485Materials And MetalsMicrosoft OfficeQuality Management SystemSolidWorksStatistical AnalysisVerification And Validation Testing