Senior Sustaining Quality Engineer

POSITION SUMMARY

The Senior Sustaining Quality Engineer will be responsible for maintaining and continuously improving the quality, reliability, and compliance of the company’s current and future products in production. This role will report to the Manager of Quality Engineering and will be responsible for leading problem resolution, supporting process improvement projects, and ensuring all products are supported to meet all Quality and compliance requirements.

SCOPE AND RESPONSIBILITIES

• Lead the resolution of manufacturing issues from root cause and failure analysis (NCMR’s, Deviations, CAPA/SCAR, etc.) through disposition for a diverse mix of on-market products.
• Lead the supplier change notification process, ensuring that process changes at suppliers comply with 21 CFR Part 820/ISO 13485 and Canary’s internal requirements for Change Management and Process validation.
• Support yield/cost improvement projects and component qualifications for on-market products.
• Lead the Final QC function, working with suppliers toward timely resolution of issues to ensure product availability.
• Lead the Supplier Audits schedule, the Supplier Approval process and Approved Supplier List maintenance.
• Support failure investigations and complaint responses.
• Support manufacturing transfer of product from development/R&D
• Additional duties assigned.

Required Knowledge, Skills, and Abilities:

• Excellent communication, documentation, and cross-functional collaboration skills.
• Strong understanding of Process Validation (IQ/OQ/PQ).
• Strong understanding of risk management techniques (Hazard Analysis, FMEA) and ISO 14971.
• Working knowledge of applied statistical techniques (Hypothesis testing, Measurement Systems Analysis, Design of Experiments).
• Hands-on experience with root cause analysis and associated quality techniques and tools (fishbone diagram, 5 why’s, etc.).
• Strong understanding of quality systems, design controls, and associated regulations (21CFR820, ISO 13485, ISO 9001, etc.).
•  Proven experience with CAPA, risk management, and sustaining engineering.
• Ability to interpret engineering drawings, specifications, and test data.
• Strong influencing and negotiation skills.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.

Preferred Knowledge, Skills, and Abilities:

• Software: Minitab, SolidWorks.
• Certifications: ASQ CQE, ISO 13485 Lead Auditor certification.
• Experience in early-stage or high-growth startup environments.
• Knowledge of electromechanical or software-enabled medical devices.
• Experience with process validation, test method validation, and reliability engineering.
• Six Sigma Green/Black Belt certification or equivalent experience.
• Experience with ERP and eQMS systems.
• Experience with Class III medical devices.

Education and Experience Requirements:

• Bachelor of Science in Engineering (Biomedical, Mechanical, Electrical, or similar).
• 5-8 years of experience in a medical device/IVD quality engineering role.

Department: Quality Assurance

Reports to: Manager, Quality Engineering

Work Location: Hybrid in Carlsbad, CA

Travel: Up to 35% travel

Employment Type: Exempt: accordingly, you are expected to work all hours necessary to complete the job responsibilities set forth above.

Salary: The estimated base salary range for the Senior Sustaining Quality Engineer, on-site role based in the United States of America is: $110,000 -$140,000.  Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, experience, education, location where the role is to be performed, internal equity, and alignment with market data. The base pay range is subject to change and may be modified in the future. Additionally, employees may be eligible for our variable cash program (bonus) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits including medical/dental/vision, FSA, long-term disability, AD&D, unlimited PTO, a flexible work environment and unparalleled culture. 

Benefits:

·      Unlimited PTO

·      FSA plan

·      Paid holidays

·      401k plan

·      Medical, dental, and voluntary vision insurance

·      Voluntary Life & AD&D

·      Voluntary Long-Term Disability

COMPANY BACKGROUND: 

Canary Medical 

Canary Medical is a medical technology company focused on commercializing smart implants in the orthopedic, cardiovascular, and aesthetics markets. The company has established a considerable intellectual property portfolio surrounding its CHIRP (Canary Health Internal Reporting Processor) technology to facilitate development of active implanted devices capable of monitoring patient function utilizing MEMs sensor technology in concert with sophisticated power management algorithms and wireless data transmission. 

The Canary ecosystem is comprised of an implantable smart device, a base station to transmit data from the device to a secure cloud structure, and a HIPAA-compliant cloud software system to store the information, convert the raw data to useful metrics, present said data on Patient and Clinician user interfaces, and mine data for clinical insights.

Canary both develops its own FDA approved products and partners with major and minor manufacturers to incorporate its smart CHIRP devices into their partner’s FDA approved devices, allowing transmission of information without clinical interpretation or medical intervention. This minimizes the regulatory burden on the medical device partner, as clinically interpreted data fall under the usual FDA regulatory pathways. 

The company has a robust product pipeline in several therapeutic areas and is targeting a smart Total Knee Arthroplasty (TKA) implant as its first commercial US product within the next months, followed in quick succession by other total joint arthroplasty products (hip, shoulder) since approximately 90% of their core technology is shared across these areas. Canary’s cardiovascular efforts are targeting aneurysm, heart valves, and coronary stents monitoring. This aspect of the Canary product pipeline is earlier in development but is likewise expected to leverage core technologies from the orthopedic pipeline to reduce time to market, project costs, and regulatory risk.

Disclaimer:

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.

Canary Medical is proud to be an equal opportunity and affirmative action employer. We make employment decisions without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability status, pregnancy, or any other basis protected by federal, state or local law. We also consider qualified applicants regardless or criminal histories, consistent with legal requirements.