Design Quality Engineer - Catheters

Description

• Lead and support new product development design control deliverables for Catheter/Disposable or Software/Hardware products.
• Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
• Lead Risk management activities including FMEAs (Process, Design, & Use), hazard analysis and other risk management file documents.
• Maintains and audits Design History Files.
• Support the review and approval of Design Validation/Verification activities including IQ/CQ/MSA/OQ/PQ activities.
• Supports the generation and completion of protocols and reports for product, process, and test method validations. (IQ/CQ/MSA/OQ/PQ)
• Provide quality and compliance support during regulatory audits and responses to government agency questions.
• QA Lead for CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
• Responsible for the review and approval of manufacturing verification and validation protocols and test reports.
• Participate in the design control and review processes, including quality planning.
• Perform quality driven statistical analysis.
• Lead activities for maintaining and updating standards across the design history file and product requirements.
• Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence.
• Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
• Conduct Supplier Audits and investigations as needed.
• Supports and leads supplier qualification process.
• Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications.
• Maintain and manage product risk management files.
• Support Post‑Market Reporting activities for disposable products (e.g. Periodic Safety Update Report, Post Market Surveillance Reporting, and Post Market Clinical Follow‑up Reporting).
• Support other projects or activities as assigned.

• Minimum of a bachelor’s degree in science, engineering, or other related technical discipline.
• 3 – 5 years of experience with engineering and development.
• Proficient understanding in medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971.
• Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required.
• Experience with statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.).
• Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5 Why, 8D, etc.).
• Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV).
• Experience with catheter products or optical imaging technology preferred.
• ASQ Certified Quality Engineer (CQE), preferred.
• Able to effectively manage workload and deliverables.
• Ability to read and interpret drawings.
• Excellent verbal and written communication skills.
• Thrives in a small size company and cross‑functional team driven environment.
• A responsible team player that takes initiative and has a solution driven mindset.
• Detail oriented with strong organization skills.
• Ability to work cross functionally and as part of a project team.
• Self‑Motivated and strong ability to adapt to change.
• Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).