About this role
JOB OVERVIEW
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:
- Bachelor’s Degree in Mechanical or Biomedical Engineering is required.
- Master's Degree in Mechanical or Biomedical Engineering is preferred.
- Must have three (3) 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 preferred.
- 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
Salary range is $97,000-$128,700