Pr. Engineer, Design Dev, R&D
Job Description
Position Summary
• Provide technical leadership and expertise in the optimization of product development
Principal Responsibilities
• Generate new product designs/concepts in an organized and consistent manner.
• Lead/Support research and development activities from Concept through Commercialization.
• Coordinate/Participate in events that provide clinical feedback and guidance, such as physician interface meetings and pre-clinical studies.
• Provide work direction, technical guidance, coaching and mentorship to R&D engineers.
• Collaborate with cross-functional teams to ensure program success.
• Perform/Lead root cause analysis activities.
• Apply detailed knowledge and expertise of Design Control per ISO 13485, 21 CFR 820, and EU MDR Requirements.
Education / Experience Requirements
• BA/BS in Engineering or physical sciences preferred.
• 8+ years of related medical device experience required.
Specialized Skills / Other Requirements
• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required.
• Must possess knowledge, understanding and skills in: generating new product designs/concepts, catheter materials, processes and design plus test methods and metrology; project management, documentation, and a working knowledge of quality systems and medical device regulations.
• Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
The pay range for this position at commencement of employment is expected to be between $152,800 - $191,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-EB1
Working Conditions / Physical Demands
TRAVEL REQUIRED: 10%
WORKING ENVIRONMENT:
☒ Office/Professional ☐ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory
The description above represents the most significant duties of this role but is not all inclusive. Other work assignments comparable to the level of responsibility indicated above may be required.