Design Quality Engineer - Asensus Surgical

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 Design Quality Engineer to join the Design and Operations Quality team, which is part of the Global Quality team.

This role will be responsible for conducting activities associated with product support and product development processes at Asensus globally from a Quality perspective, to provide a compliant, safe and effective product that meets customer needs.

Activities include generation and management of SOP's, generation and review of documentation, audits, participation in process improvement programs, supporting the product development teams ensuring the quality objectives are understood and achieved. 

The Quality Engineer shall ensure that mechanical, electrical, and software systems used in development, manufacturing and as part of medical devices are established according to requirements.

What You'll Do

• Participate in Design Control/Assurance activities globally; assists in the development of design concepts, prototypes and product specifications as part of the development team. 
• Provides guidance to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles.
  
• Acts as a key contributor in writing and reviewing protocols, reports, work instructions and SOPs to support product and process development
  
• Defines and develops risk management activities including Supplier Qualification and Development activities
  
• Builds and maintains strong and impactful relationship with global R&D for Design quality aspects
  
• Participates within the design change process by assisting with development and documentation of impact analyses related to design, process, suppliers, etc.
  
• Supports improvements to the QMS as a result of quality events, audits or regulatory changes to ensure compliance with FDA 21 CFR 820, ISO 13485 and adoption of best practices.
  
• Supports internal audits and CAPA activities as applicable
  
• Ensures compliance with Asensus quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
  
• All other duties as directed.
  

What You Bring

• Bachelor's degree in Biomedical or Electrical engineering. Master's degree in engineering discipline preferred.
• 2+ years in a quality engineering role in the medical device field
• Some knowledge of key standards / regulations related to medical device manufacturing, including but not limited to ISO 13485, 21 CFR Part 820, MDSAP, ISO 14971, and EU MDR 2017/745.
• Some experience and understanding of design control, disciplined product development processes, regulatory and quality requirements.
• Some knowledge of common quality and statistical tools
• Experience working in cross-functional teams
• Ability to problem solve and manage workload
• Self-starter with the ability to work toward goals
• Must be able to work well in teams cross functionally and influence teams
• Must be comfortable presenting and explaining data/details
• Ability to understand technical aspects of the product and communicate it with relevant stakeholders

Special Skills

• ASQ Certification as Certified Quality Engineer or Reliability Engineer is a plus
• Experience in Human Factors/Usability Engineering for Medical Device is a plus
• Experience in New Product Development/Introduction is a plus
• Experience with Electromechanical medical devices

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.