Staff Product Development Engineer

Who We Are

At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find.

The role

Asensus is hiring a Staff Product Development Engineer to join the Product Development team. This role will be responsible for leadership, support and oversight for the activities related to development, verification, and validation of surgical robotic systems. This position requires a positive and collaborative approach to product evaluation. Additionally, this role requires cross-functional interaction as a team member in the new product development process

What You'll Do

• Lead and direct activities relating to the building, testing and evaluation of surgical robotic systems.
• Develop strategies for both product and system level verification testing. Write advanced test plans and technical reports.
• Execute verification and validation studies and independently write plans and reports.
• Applies extensive technical expertise and has full awareness of other related disciplines to solve complex technical problems.
• Regularly develops technical solutions to complex problems requiring ingenuity and creativity.
• Review and analyze, including formal reports, such things as product requirements, test results, patents, etc.
• Comply with regulatory requirements, including company design control procedures.
• Exercises considerable latitude in determining technical objectives of assignment.
• Mentor and direct the work of more junior engineers.
• Assist in document control and maintenance of design history file.

What You Bring

• Bachelors Degree in an engineering discipline (biomedical engineering, systems engineering, mechanical engineering, or related) with 12+ years experience in FDA Regulated Industry, preferably Medical Device.
• Excellent attention to detail and ability to cross-reference documentation from different areas to ensure consistency and compliance to established requirements.
• In-depth knowledge of standards and regulations including 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
• Proven ability to interpret, analyze, and present technical information using practical judgment.
• Extensive experience in Product Lifecycle Management (PLM) systems, such as Arena
• Experience with Project Management and Test Management tools, such as JIRA
• Excels at working in a cross-functional team environment.
• Excellent written and oral communication skills.
• Demonstrated problem solving skills.

What We Offer 

• A culture-driven environment to achieve our mission and deliver remarkable results
• Coworkers committed to collaboration and winning the right way
• Quality products that improve the lives of our customers and patients
• Ability to discover your strengths, follow your passion and find your own rewarding career
• Flexible, engaging work environment
• Competitive benefits package

DEI Statement

At Asensus, we believe in contributing to a society that welcomes diverse voices and values differences in lived experiences, culture, religion, age, gender identity, sexual orientation, race, ethnicity, and neurodiversity. We are committed to ensuring this same environment for our employees - a culture where individuals feel safe, heard, and respected. We celebrate the uniqueness of our global workforce and know that only through inclusion, ongoing learning, and partnership can we succeed. Together we are all stronger.