Sr. Design Quality Engineer

Actively participate in product development and transfer activities, ensuring product and process conformance to 21CFR820 and ISO13485 standards. Prepare, execute and review validation methods and protocols, test methods, statistical analysis methods, and specification derivation and assignment. Review new and modified product designs for quality characteristics; including but not limited to manufacturability, serviceability, and conformance to product requirements. Participate in risk management activities for new products in development and on-market products. Ensure human factors engineering principles are considered in both risk management and design controls. Support routine quality assurance tasks and projects.

Essential Job Functions:

• Participate in supporting design quality disciplines, decisions, and practices in design and development of medical device products and facilitate the application of design controls, human factors engineering, and risk management.
• Lead or support risk management activities, including analyzing field data to support new product development, supporting failure mode effects analysis, generation of risk management plans/reports, and completion of hazard analysis.
• Ensure Design History File (DHF) content completion, integrity, and regulatory standards compliance; collaboratively identifying, communicating, and resolving gaps.
• Ensure compliance with procedural and documentation requirements of FDA and ISO design controls.
• Prepare, executes and approves/reviews related to validation methods, validation test plans, protocols, test methods, statistical analysis methods and specification development.
• Reviews new and modified product designs for quality. Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
• Support Design Transfer Activities domestic and international.
• Develop, implement and monitor appropriate quality metrics to support Management Review, Customer Complaints, MDR, CAPA, NCR and Customer Satisfaction.
• Partner with cross-functional teams to manage investigations for complex issues. Develop team to perform experiments and tests for complex issues (including writing and executing protocols).
• Understanding and professional experience in root cause analysis, statistical methods, risk management, design of experiments, and process validation.
• Experience in Health Hazard Analysis (HHA) process.
• Hands on participant in early stages of product development including but not limited to physician interaction, component engineering, competitive product and prototype testing.

Requirements:

Qualifications:

• Use statistical tools to analyze data, make acceptance decisions and improve process capability (SPC, DOE).
• Acts as a contributor for Quality organization by developing validation plans.
• Drive corrective, preventive, and closure actions for project issues related to quality and/or test nonconformance.
• Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer.
• Knowledge in applicable Medical Device Quality regulatory requirements and standards.
• Experience in design and implementing quality improvement processes in support of business plans - cross functional projects with R&D, Upstream Marketing & Marketing.
• Demonstrates high level problem-solving, analytical and critical thinking skills including high discretion/judgment in decision making.
• Professional communication and interpersonal relationship skills including developing and managing cross functional relationships management and ability to drive achievement of objectives.
• Experience with Neurovascular, Cardiovascular, and Peripheral Vascular devices.
• Experience in product realization and medical device design quality aspects.
• Advanced Statistics - 2+ years working with Minitab, DOE, Capability analysis, stability analysis, graphical analysis etc.
• Reliability, Risk Management and Analysis experience.
• Test Method development and Validation skills/experience.
• Six sigma certification / ASQ certifications a plus.
• Experience with inspection plans and inspection tools/equipment qualification.
• Effective verbal and written communication skills a must.
• Strong interpersonal and organizational skills required.
• Proficient in Microsoft Applications (Word, Excel, PowerPoint etc..) required.

Minimum Qualifications:

• Bachelor's Degree in Engineering (BS).
• Minimum 7 years in the medical device industry, preferably in catheters. Considerable hands-on experience in medical device manufacturing with strong working knowledge of 21 CFR Part 820, ISO 13485 and EN ISO 14971.
• CQE Certification, Six Sigma Certification or Lean Manufacturing is considered a "plus".

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or other customers; manual dexterity required for occasional reaching and lifting of small objects, and operating office equipment. Must be able to sit for an extended period of time and operate a computer for an extended period of time.