This position is responsible for developing and implementing systems to ensure products and/or services are design and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of the company’s quality system processes related to complaint handling, process validation, internal nonconformities, product development and supplier quality to provide engineering analysis and
 support in verification, validation and problem solving. 

KEY RESPONSIBILITIES: 

• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations. 

• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes. 

• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Implements problem solving methodologies to reduce internal and external defects. 

• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Validates key design inputs including usability, reliability, performance, ability to manufacturer, safety and effectiveness. 

• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation.  Identifies and implements product and process controls consistent with the outcome of the risk management process. 

• Author validation, verification and inspection assessments to ensure product test and manufacturing data support product release. Select appropriate tests and sampling sizes based on criticalabilandstatistical calculations. 

• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others as required. 

• Conduct computer system validation and stay current with validation regulatory requirements. 

• Participates in special projects and perform other duties as required. 

MINIMUM WORK EXPERIENCE: 

3or more years of engineering experience, ideally within the medical device industry, including roles within product development or manufacturing engineering. Experience in a disciplined engineering environment. 

PREFERRED EDUCATION: 

A Bachelor's Degree in engineering, typically electrical or mechanical. Master's degree in engineering, an MBA or global equivalent a plus. ASQ Certification also a plus.  

GENERAL SKILLS & COMPETENCIES: 

• Previous experience in product engineering, manufacturing engineering and/or quality
   engineering within the Medical Device Industry. 

• A working knowledge of LEAN and Six Sigma concepts and tools.  

• Outstanding verbal and written communication skills 

• Excellent presentation and public speaking skills 

• Excellent independent decision making, analysis and problem solving skills 

• Understand and act on financial information that contributes to business profitability 

• Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility 

• Excellent planning and organizational skills and techniques 

• Communicate effectively with senior management 

• Good negotiating skills and ability to effectively manage outsourced relationships 

SPECIFIC KNOWLEDGE & SKILLS: 

• Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR
  and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards. 

• Demonstrated success in the implementation of problem solving methods and tools 

• Understanding of the effective implementation of the entire risk process, including the
  identification and implementation of appropriate controls in product development and/or operations. 

• Experience in product verification/validation, process validation and test system development and implementation. Experience in the development and implementation of processes andtesting meant to satisfy quality and regulatory standards in the medical device industry, as well as drive product and process quality. 

• Practical experience with the implementation of statistical tools and techniques. 

• Experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects. 

• Strong understanding of best practices related to supplier quality and supplier development

• General knowledgeable in computer system validation and related regulatory requirements 

TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS:

• Travel – typicallyless than 10%

• Position typically works in an office environment whether on site or remote where environmental conditions are stable

• While performing the duties of this job, the employee routinely is required to sit for extended periods of ti