Sr R&D Test Engineer

About the role

The Senior R&D Test Engineer plays a key role in developing safe and effective devices. This position has a critical eye on the physical behavior of the Company’s products and works closely with cross-functional partners to develop and realize the full potential of our technology.

Responsibilities

• Design and document test methods and associated fixturing/automation to support both explorative, characterization, and formal verification testing of the Company’s products.
• Measure and quantify the physical characteristics and performance of the device by experimental design.
• Develop test methods and equipment for evaluating and comparing performance of devices for concept selection, design optimization, and design verification in close collaboration with the preclinical and design groups.
• Collaborate with cross-functional partners to identify opportunities, implement new solutions, and incorporate continuous improvements stemming from technology advancement, FDA feedback, and/or applicable standards.
• Develop and maintain the company’s bench testing technologies & competencies, including test method validation and training.

Requirements

• Bachelor’s degree in engineering, or related discipline and a minimum of 5 years of related experience or master’s degree in engineering with 2 years of related experience in the medical device or related regulated industry; or equivalent combination of education and work experience.
• Experience with product testing, test method development, test method validation and automated data collection.
• Ability to design and document test fixtures including the generation of technical drawings.
• Working knowledge of standard laboratory equipment such as mechanical tests frames, load cells, pressure sensors, environmental conditioning chambers, scales, etc.
• Use of statistical analysis techniques, gage R&R, & DOE.
• Strong fundamentals in fluid mechanics and/or experience with computational fluid dynamics is a plus.
• Experience working under regulated quality systems such as GMPs, ISO 13485/9001, and the MDD.

Qualifications

• Must be able to travel up to 10% of the time.

Skills

• Entrepreneurial spirit.
• Persistence to succeed in a start-up environment.
• Ability to work in a self-directed manner with minimal direction and supervision.

Benefits

• Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Pay

Salary Range: $132,000 – 158,000 annually

Schedule

This position is on-site and full-time with some travel.