Principal Quality Engineer Design Assurance (NPD)

• Lead development and execution of Design Assurance strategies and quality plans across the product development lifecycle to ensure compliance with applicable regulatory and internal quality requirements.
• Provide strategic quality input to product development teams and ensure effective implementation of design controls verification validation and transfer activities.
• Establish and maintain quality engineering methodologies procedures and best practices supporting product realization and continuous improvement.
• Review product requirements design outputs test protocols and development documentation to ensure alignment with quality and regulatory expectations.
• Utilize quality metrics and data analytics to identify trends support decision-making and drive proactive improvements.

• Lead Risk Management activities in accordance with ISO 14971 and internal procedures.
• Oversee development and approval of Risk Management Reports and support creation and maintenance of Use Risk Design Risk Process Risk and benefit-risk documentation.
• Evaluate quality and reliability impacts from design changes complaints CAPAs nonconformances supplier issues and process modifications.
• Conduct ongoing benefit-risk assessments throughout the product lifecycle and escalate unacceptable risks appropriately.

• Serve as the technical authority for sterilization microbiology contamination control and biocompatibility activities as applicable.
• Develop review and approve sterilization validation protocols reports requalification strategies and associated documentation.
• Provide technical oversight of terminal sterilization modalities with emphasis on Ethylene Oxide (EO) sterilization.
• Generate and maintain Biological Evaluation Plans (BEPs) assess testing outcomes perform gap assessments and determine biocompatibility testing strategies.
• Interpret laboratory results and translate findings into product and regulatory decisions.
• Serve as primary technical liaison with contract laboratories manufacturing sites suppliers and development teams.

• Establish and maintain quality expectations with suppliers contract manufacturers and external laboratories through quality agreements and performance monitoring.
• Support supplier qualification audits technical assessments and remediation activities.
• Drive supplier quality improvements through effective CAPA SCAR and risk mitigation activities.

• Support and enhance Quality Management System processes to maintain compliance with applicable regulations and standards.
• Review and assess DCOs CAPAs complaints NCMRs/NCRs and change activities for quality and risk impact.
• Prepare and support technical documentation for regulatory submissions audits inspections and management reviews.
• Support internal and external audits and serve as a technical representative during regulatory inspections.

• Act as a technical mentor and coach to Design Assurance Quality Engineering and cross-functional teams.
• Provide technical leadership without direct authority across multiple functions and levels of the organization.
• Develop and deliver training on design assurance sterilization biocompatibility and quality system requirements.
• Promote Quality Policy Quality Objectives and continuous improvement initiatives.
• Ensure applicable personnel are trained on procedures GMP requirements and regulatory expectations.

• Bachelors degree in Engineering Life Sciences Microbiology Biomedical Engineering or related technical discipline with 12 years of progressive experience in medical devices or regulated industries; or equivalent combination of education and experience.
• Masters degree preferred.
• Experience supporting catheter-based endovascular neurovascular or other Class II/III medical devices preferred.
• Demonstrated technical leadership in Design Assurance and product development quality.

• Deep expertise in medical device Design Controls and product development processes.
• Strong knowledge of FDA Quality System requirements including 21 CFR Part 820 / QMSR and ISO 13485.
• Strong working knowledge of ISO 14971 risk management principles.
• Advanced experience with CAPA nonconformance management and supplier quality systems.
• Demonstrated experience supporting audits and regulatory inspections.

• Extensive experience with terminal sterilization methods (EO preferred).
• Working knowledge of:
  • ISO 11135 Ethylene Oxide Sterilization
  • ISO 11737 Series Microbiological Methods
  • ISO 11138 Series Biological Indicators
  • ISO 10993 Series Biological Evaluation
  • AAMI TIR52

• Exceptional written and verbal communication skills.
• Ability to influence and drive alignment across all organizational levels.
• Strong analytical and problem-solving capabilities.
• Ability to manage multiple priorities in a dynamic environment.
• Proficiency with Microsoft Office and electronic quality systems.

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.