Design and Risk, Quality Engineer
Department: Quality Assurance
Reports to: Global Director of Quality Assurance
FLSA Status: Exempt
The Design and Risk, Quality Engineer is responsible to facilitate compliance to applicable internal and external requirements during the product development cycle and commercialization of new products including, but not limited to Risk Management, Usability, Design Control Process, Design Change, Verification and Validation, and all areas of the Quality Management System; participate in cross-functional teams to find compliant solutions; facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance and implementing improvements for manufacturability while ensuring that the Company’s new product introductions and product design change activities are in compliance with all applicable laws, FDA/EU regulatory requirements, industry standards, and the Company’s Policies and Procedures. This position supports deployment and continuous improvement of internal development procedures including Design Control, Risk Management, and Statistical Techniques to drive robust designs and support the life-cycle maintenance of product risk and design documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned from time to time.
- Actively participate in new product development projects ensuring that product design inputs are clear, concise, testable and appropriate and that design outputs confirm compliance to the design inputs.
- Assure that product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met; Review test methods for quality of verification and validation of the method; Test method validation is an element of assuring verification/validation is acceptable.
- Participate on design teams to assure customer product requirements and quality requirements are documented and addressed. Collaborate with project design and test engineers in the development of Design Verification and Validation Protocols and Reports.
- Review and approve design verification and validation test plans, protocols and reports; Ensure V&V results demonstrate compliance to medical device standards.
- Provide quality engineering guidance to product development teams throughout the product development process (PDP) to ensure compliance to the required PDP deliverables, resulting in the development of safe and effective medical devices.
- Participate in Design Reviews and Product Development Reviews.
- Collaborate with R&D, provide quality technical support, and facilitate the successful execution of the Design Control Process.
- Support rigorous planning activities in relation to design control deliverables.
- Responsible for overseeing Quality Engineering deliverables required within the product development process; Manage deliverables from the design process including DHF & project files reviews, and Post Market Surveillance Plans & Reports.
- Maintain quality documentation related to new product launches.
- Create product inspection criteria and first article verifications.
- Plan and lead the analysis, test, verification, inspection, and integration of design to ensure the quality of components and/or products.
- Responsible for the identification and interpretation of applicable international and domestic regulations and standards – ensure that Product Development integrates these requirements to product designs.
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
- Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
- Partner with manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
- Participate in sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
- Support in the evaluation and qualification of new supplier materials following a defined new product development process.
- Assure organizational understanding and compliance of design quality with regard to risk management requirements and international standards.
- Participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, within product teams and updates to existing product lines.
- Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
- Assist project teams to identify Compliance (safety, regulatory and business) risks during the product development cycle.
- Oversee the Risk Management and Usability processes.
- Identify and manage risk throughout the development process and sustaining efforts with the use of FMECA, Post-Market Surveillance Reports, Risk Management Plans/Reports, and other risk management tools including new EU MDR requirements.
- Responsible for coordinating Health Risk Assessment team with support of lead/manager when needed for evaluation of on market product; demonstrate efficient and effective analysis of situation, including problem definition and impact.
- Support rigorous planning activities in relation to risk management deliverables.
Process Improvements & Reliability
- Participate in continuous improvement of design control process and project management planning.
- Communicate significant issues or developments identified during quality assurance activities and provide recommended improvements.
- Utilize Design for Six Sigma (DFSS) tools to promote a disciplined approach to product and process design in order to ensure product quality and process capabilities.
- Participate in corrective and preventive actions (CAPA)-related activities, including CAPA ownership, if appropriate.
- Drive high quality, safe product development while working with cross-functional teams.
- Promote continuous improvement.
- Support the New Product Development team with all measurement and testing requirements and data analysis.
- Provide expertise in statistical analytical techniques.
- Provide fact-based quality analyses.
- Improve the reliability of new product development processes.
- Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Analyze preliminary plans and develop reliability engineering programs to achieve company, customer and governmental agency reliability objectives. As necessary, proposes changes in design or formulation to improve system and/or process reliability.
- Work closely with cross-functional personnel to identify and control potential quality issues in new products.
The Design Quality & Risk Management Engineer will have no direct reports.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Education and Experience
- Minimum Bachelor (BS) degree in Engineering or relevant Technical/Scientific degree from a 4 year college; at least 5-10 years related proven experience in Design Quality and/or Risk Management.
- Experience in requirements analysis, including testable and measurable specifications; Experience with test methods and standards for the design, verification, and validation of medical device products; Experience with reliability analysis and test methods and test method validation.
- Experience with appropriately assessing written design and device documentation as the principle advocate for compliance; Expert knowledge of EU MDR (Medical Device Regulations).
- Technical Knowledge & Skills
- Complete understanding and wide application of technical principles, theories, and concepts in the engineering field.
- Proficient at problem solving and analytical techniques such as Is/Is Not Matrix, Fish Bone Diagram, Concentration Diagrams, Contradiction Matrix and Design of Experiments (DoE).
- Proficient in use of statistical analysis and associated tools (e.g. Tableau, Minitab, etc.).
- Strong comprehension and demonstrated ability to apply critical regulatory standards to procedural updates and project deliverables (FDA CFR 820, ISO 13485, ISO 14971).
- Firm understanding of DFMEA, pFMEA and Risk Management processes; experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP.
EMPLOYMENT WITH APYX MEDICAL
All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole absolute discretion.
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