Senior Design Assurance Quality Engineer

Primary Duties and Responsibilities

• Lead the design assurance activities in accordance with FDA regulations (21 CFR 820), ISO 13485, and other relevant standards.
• Ensure design controls are followed throughout the product lifecycle, from concept through to commercialization, ensuring compliance with applicable regulatory standards.
• Review and approve design documentation, including Design History Files (DHF), Design Outputs, and Design Inputs.
• Lead risk management activities for new product development and existing product improvements in accordance with ISO 14971.
• Conduct risk analysis, risk assessments, and prepare risk mitigation strategies to ensure the safety and efficacy of medical devices.
• Drive the use of appropriate tools (e.g., FMEA, Fault Tree Analysis, Severity Assessments) to identify and mitigate design risks.
• Partner with design teams on verification and validation activities to ensure design outputs meet design input requirements and regulatory expectations.
• Review V&V protocols, test data, and ensure that all verification and validation activities are appropriately documented.
• Collaborate with cross-functional teams to define test plans, specifications, and criteria.
• Collaborate on test and inspection method development and validation.
• Identify opportunities for quality improvements in design and manufacturing processes.
• Develop and implement corrective and preventive actions (CAPA) in response to design and product quality issues.
• Support internal and external audits, including FDA, ISO, and other regulatory audits.
• Support the preparation of regulatory submissions (e.g., 510(k), CE marking) and ensure documentation aligns with global regulatory requirements.
• Maintain and update relevant documentation, such as risk management files, design verification/validation reports, and CAPA reports.
• Collaborate with product development, R&D, manufacturing, and regulatory affairs teams to ensure design quality, risk mitigation, and compliance.
• Provide technical expertise and guidance to junior engineers and other team members on design assurance practices.
• Lead and manage design assurance-related projects, ensuring timely and successful completion.
• Prepare and present project status updates, risk assessments, and quality reports to senior management.
• Support the investigation and resolution of design-related issues and non-conformances.

Skills, Knowledge, Experience & Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, or a related field. Advanced degree preferred.
• Minimum of 5-7 years of experience in design assurance quality engineering in the medical device industry.
• Strong knowledge of design control and risk management principles.
• Experience with regulatory standards such as ISO 13485, 14971, and FDA 21 CFR Part 820
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Able to work effectively in a team environment and manage multiple projects simultaneously.
• Certification in quality engineering (e.g., CQE, CQA) is a plus
• Experience with quality management software, preferably Grand Avenue Quality Management Software.
• Strong analytical and problem-solving skills. Lean and/ or Six Sigma experience a plus.

Compensation

Target base salary range: $110,000 – $130,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• Competitive compensation package, including salary, performance-based bonuses, and stock options.
• Career development opportunities and a chance to be part of a growing company that values its employees.

Our Health and Wellness Offerings

• Medical, Dental, and Vision Offerings
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays
• Paid Vacation
• Employee Assistance Program
• Inclusive Team Environment