Lead sterilization, microbiology and biocompatibility quality activities across product development and manufacturing. Develop and execute quality plans, risk management, validations, supplier qualifications and audits. Oversee testing labs, analyze results, manage CAPAs/NCMRs, prepare regulatory submissions, and provide training and QA system compliance for medical device products.
Title: Principal Quality Engineer - Design Assurance (NPD)
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 –
The Principal Quality Engineer is the subject matter expert who establishes processes, protocols, methods, and techniques to ensure compliance with quality standards and regulatory requirements during the development, manufacture and distribution of our medical device products. This role will involve leading sterilization and biocompatibility activities and/or overseeing the work of more junior team members or contracted testing laboratories, depending on focus area.
Product Development & Design Assurance
- 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.
What You’ll Bring – minimum requirements for this role:
- Bachelor’s 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.
- Master’s 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.
Required Technical Competencies
- 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.
Preferred Specialized Expertise
- 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.
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: $173,000 – 192,000 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.
Imperative Care Campbell, California, USA Office
Dell Ave, Campbell, CA, United States, 95008
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