Principal Design Assurance Engineer

Job Description and Responsibilities:

From day one, you will be boots-on-the-ground with engineers in support of our products. You will execute and improve design control activities and work with multiple engineering teams (Surgery, Implant, Robot), learning the existing frameworks and developing a sustainable and scalable process. The ideal candidate is someone with an engineering mindset, strong design controls and risk management skills, able to parse important details from ambiguity, and comfortable collaborating with product development engineers and manufacturing engineers. You will help the nascent products in the pipeline efficiently complete medical-grade design and manufacturing processes and, by doing so, ensure the highest standard of product reliability and performance.

• Ensure that compliance to customer, risk management, quality and design control requirements is demonstrated in design and development projects
• Help to ensure successful transfer of the design to manufacturing
• Participate in decisions on scope of work, selection of materials/equipment/test methodology, design reviews, and in decisions on design changes to meet revised specifications
• Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products
• Implements methods by working alongside engineers for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment
• Diagnose and resolve manufacturing and quality system issues
• Participate in performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes
• Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents
• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA
• Support Product/ Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data
• Follows all safety and production standard operating procedures
• First principles when designing a process ensuring it’s not cumbersome for non QS members, and can support rapid iterations.
• Defining problems as much as solving them.
• Know that what matters is delivering a solution that works every time and is efficient for engineers.
• Cross-disciplinary team member. You are excited to work with and learn from software, mechanical, electrical, materials, biological engineers, and neuroscientists. You are comfortable communicating across teams.
• Resourceful, flexible and adaptable; no task is too big or too small.

Key Qualifications:

• Bachelor’s Degree in science or engineering, or equivalent in experience and ability.
• Strong understanding of engineering first principles.
• Excellent verbal and written communication.
• Relentless attention to quality.
• Experience building processes that are scalable.

Preferred Qualifications:

• 2+ years of experience with rigorous design control processes in the medical device industry.
• 1+ years of experience working in risk management.
• Experience with medical device best practices and regulatory requirements for FDA and/or international bodies. For example, Design Controls, GMP, GCP.