SUMMARY:

The Senior Quality Engineer will support and ensure the implementation of robust and compliant design control practices across both new product development and sustaining engineering activities for the iovera product line. This role serves as a quality representative within cross-functional teams, driving compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485) and internal quality standards. The Senior QE will play a key role in evaluating design changes, risk management activities, and quality documentation throughout the product lifecycle, while also supporting complaint investigations and continuous improvement initiatives.
Responsibilities:
Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Collaborate with R&D and cross-functional teams to ensure design control requirements are met throughout all phases of product development and lifecycle management.
• Support design verification and validation activities, risk management, and design review processes to ensure products meet applicable safety, performance, and regulatory requirements.
• Evaluate and provide quality input on engineering design changes, ensuring appropriate documentation, traceability, and risk assessment are conducted.
• Contribute to the continuous improvement of design control processes, templates, and procedures to align with current regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality oversight to maintain compliance and support product improvements.
• Support the complaint handling process by reviewing and analyzing complaint data, participating in root cause analysis, and identifying design-related trends or failure modes.
• Assist in the preparation of quality deliverables for regulatory submissions, including 510(k)s, technical files, and IDE-related documentation.
• Support internal and external audits by preparing and presenting relevant design history and risk documentation.
• Collaborate with cross-functional teams including Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to ensure consistent and aligned approaches to design quality.
• Contribute to management review inputs and quality metric tracking related to design control and product quality performance.
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits.

EDUCATION AND EXPERIENCE:

• BS Degree or higher in engineering field required (e.g., Electrical, System, Mechanical engineering)
• Experience with design or sustaining engineering required
• Minimum 7 years’ experience in design or sustaining engineering required

Knowledge, Skills, and Abilities:

• A practical and working knowledge of ISO 13485, 21 CFR 820
• Experience with Design Controls
• Statistical knowledge and understanding of measurement uncertainty
• Detail oriented, well organized and have excellent communication skills
• Able to accomplish objectives with minimal supervision

SUPERVISORY RESPONSIBILITIES:

This role does not have supervisory responsibilities.

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Collaborate with R&D and cross-functional teams to ensure design control requirements are met throughout all phases of product development and lifecycle management.
• Support design verification and validation activities, risk management, and design review processes to ensure products meet applicable safety, performance, and regulatory requirements.
• Evaluate and provide quality input on engineering design changes, ensuring appropriate documentation, traceability, and risk assessment are conducted.
• Contribute to the continuous improvement of design control processes, templates, and procedures to align with current regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality oversight to maintain compliance and support product improvements.
• Support the complaint handling process by reviewing and analyzing complaint data, participating in root cause analysis, and identifying design-related trends or failure modes.
• Assist in the preparation of quality deliverables for regulatory submissions, including 510(k)s, technical files, and IDE-related documentation.
• Support internal and external audits by preparing and presenting relevant design history and risk documentation.
• Collaborate with cross-functional teams including Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to ensure consistent and aligned approaches to design quality.
• Contribute to management review inputs and quality metric tracking related to design control and product quality performance.
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits