Sr R&D Engineer - Product Design & Development

Integer Holdings Corporation•Plymouth, MN

1d•$120,450 - $176,660

About The Position

This individual will be a design-focused technical leader responsible for driving the design and development of advanced catheter-based devices within Integer’s Cardio & Vascular OEM and Contract Design business functions. This role leads end-to-end product design, with a strong emphasis on translating clinical needs to use requirements, design inputs, and simulated use validation to ensure clinical performance.

Requirements

Strong familiarity with medical device product development procedures for OEM and contract design type projects. Activities include determining and documenting customer use requirements, concept selection, user specification, design traceability, regulatory strategy, DFMEA, etc.
Strong familiarity with current medical device offerings across the industry.
Strong familiarity with FDA and ISO/EU regulatory requirements and procedures.
Demonstrated ability to lead activities across a broader team.
Advanced problem-solving skills.
Effective communication, presentation, follow-through, and organizational skills.
Ability to effectively work and communicate with coworkers on all levels of the organization including senior leadership.
Bachelor’s degree in biomedical engineering, mechanical engineering, or related field.
10 years in the medical device OEM/contract design field.

Nice To Haves

Master’s degree or higher preferred.

Responsibilities

Subject matter expert in medical catheter design and validation activities including design for specific clinical applications and validation/verification test selection relevant to the intended clinical use.
Develop new and unique approaches to solve complex design problems and advance technology beyond current market offerings.
Familiar with catheter manufacturing processes; designs products with manufacturability in mind by considering current manufacturing capabilities and/or investigating, developing, and implementing new process technologies.
Maintains liaison with individuals and business units including the regulatory, clinical, and commercial teams with responsibility for acting independently on technical matters pertaining to his/her field.
Provide technical guidance to leadership on overall OEM product strategy.