Principal R&D Engineer

Principal R&D Engineer
1 year
Plymouth, MN, 55442

Job Description:
We are seeking an experienced Principal R&D Engineer to join our EP Catheter product development team at our Plymouth, MN location. In this role, you will be focused on delivering the future in Electrophysiology catheters. This role will involve a range of responsibilities including but not limited to product requirement development, device testing and data analysis, risk management documentation and test method development and validation.

Duties and Responsibilities:

• Utilize multidisciplinary engineering knowledge and experience to develop new products specific for catheter-based technology.
• Identify and mitigate project risks
• Plan, schedule and coordinate project tasks and activities.
• Effective communication skills with management and cross functional team members.
• Utilize structured problem-solving approaches to resolve design investigations during development
• Run empirical and experimental analysis utilizing various analytical design tools.
• Work with outside consultants, vendors and the medical community.
• Support bench / animal testing and clinical evaluations.
• Establish product requirements and specifications
• Establish test method and model development
• Ensure compliance with procedural and documentation requirements of, FDA, ISO and other regulatory bodies.

Experience and Education Requirements:

• Bachelor's degree in Mechanical Engineering/related degree.
• 8+ years of engineering experience, mainly in Research & Development engineering
• Project (product development) leadership and management skills
• Experience developing and testing medical devices.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational skills, as well as attention to detail.

Preferred Qualifications / Education

• Experience in electrophysiological, mapping & catheter ablation, disposable medical devices.
• Experience with electrical safety standards (IEC 60601) and relevant catheter test requirements and methods
• Experience in system level requirements (catheter and associated capital equipment)
• Experience working in a broader enterprise/cross-division business units model
• Experience and knowledge of electrophysiology catheter applicable standards
• Experience in risk management (Hazard analysis, DFMEA, UFMEA, etc) documentation creation