The Role
The Director of Design Assurance oversees quality engineering for product development, manages compliance with regulations, and leads a team to ensure quality improvement and alignment with business goals.
Summary Generated by Built In
Title: Director, Design Assurance
This position is based in our Campbell, California offices. This position is on-site, full-time.
Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
This role interprets functional strategy and set plans that meet quality engineering goals and objectives aligned to new product development and sustaining commercial products. This position will direct and oversee all activities of assigned staff who contribute to and support company priorities for new product development and sustaining of commercial products, delivering state of the art product quality and reliability. The role provides leadership in defining and implementing quality engineering principles and processes that facilitate the realization of Imperative Care’s business objectives.
- Lead the design assurance team and ensure compliance with domestic and international regulatory standards (e.g., FDA, CE marking, etc.).
- Build and sustain relationships with cross-functional peers in R&D, Clinical, Engineering, and Regulatory bodies.
- Champion quality engineering principles and foster a company-wide continuous improvement mindset, promoting shared responsibility for quality.
- Provide direction and mentoring to the team to ensure success and alignment with company goals.
- Participate in audits by external bodies (Notified Body, FDA, etc.) and internal audits to maintain regulatory compliance.
- Oversee quality and compliance issues, actively resolving them and providing guidance across functions.
- Recommend solutions for quality improvement and resolve any compliance issues identified.
- Promote a patient-centric, continuous improvement approach in the design assurance organization.
- Contribute to new product development and sustaining efforts, ensuring compliance with design control, risk management, standards, and change management.
- Use performance metrics to identify quality issues early and implement corrective actions.
- Identify and implement new technologies, methods, and systems to enhance quality and efficiency.
- Utilize statistical analysis techniques, including SPC (Statistical Process Control), Design of Experiments, and reliability testing to improve processes.
- Recommend quality assurance sampling plans based on process capabilities and equipment.
- Provide technical guidance and training to the QA department on statistical analysis, experimental design, and other quality assurance topics.
- Represent QA engineering during New Product Development (NPD) and Design Reviews.
- Ensure robust design control and risk management practices are followed, driving improvements in test methods, validation, and verification processes.
- Provide expertise in risk management, test method validation, verification, and reliability testing for new and existing products.
- Hire, coach, and develop staff to ensure the success of the design assurance team.
What You’ll Bring:
- Bachelor’s degree in engineering or related field, and a minimum of 10 years of experience, including 3+ years of managerial experience; or equivalent combination of education and work experience.
- Expert knowledge of FDA regulations, EU regulations, and ISO standards.
- Superior ability to manage complex projects simultaneously.
- Proven ability to create improvements in processes and systems.
- New product development experience required with experience in systems engineering a plus
- In depth knowledge of Risk management and applications
- Preferred ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).
- Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971, 62366; IEC 60601-1 and related regulations.
- Excellent leadership and managerial skills with the ability to be flexible, adaptable and to work under pressure.
- Excellent verbal, and written communication skills and effective interpersonal skills.
- Proactive leader who can determine deficiencies, communicate them effectively through the organization, and follow through to resolution.
- Ability to work effectively with employees at all levels of the organization.
- Willingness to perform “hands-on” troubleshooting and problem-solving activities.
- Demonstrated business acumen and ability to lead technical aspects of Design and Process Validation principles.
- Ability to comprehend principles of engineering, physiology, and medical device use
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.
Join Us! Imperative Care
Salary Range: $218,000 – 234,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
Top Skills
Design Of Experiments
Eu Regulations
Fda Regulations
Iso Standards
Risk Management
Statistical Process Control
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The Company
What We Do
Imperative Care is a Silicon Valley-based medical technology company focused on developing the next generation of innovative solutions to address the vast and urgent needs in stroke intervention and peripheral thrombectomy. With a physician-driven approach and a culture of rapid innovation, we are working to improve every aspect of the stroke procedure with the goal of bringing patients the best care possible. We have two 510(k) cleared product platforms, as well as an expansive technology development pipeline. Follow us for updates as we work to change the way stroke is treated.
For important safety and risk information, visit bit.ly/3yWkfEJ.
