Senior Design Quality Engineer

JOB TITLE: Senior Design Quality Engineer

DEPARTMENT: Quality Assurance

REPORTS TO: Quality Director

JOB SUMMARY

In this role, the Senior Design Quality Engineer provides quality leadership, governance, and engineering best practices to medical device product development programs. This role will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the development lifecycle into manufacturing and sustainment. The incumbent will provide quality leadership for development projects from product inception through design transfer, including partnering with Manufacturing to establish and qualify/validate the manufacturing process as part of NPI. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets.

They will partner with R&D, Manufacturing and Engineering to establish consistency across product platforms, drive engineering design improvements, and lead implementation of design control related strategies and objectives. This role will drive harmonization and alignment of the company's design control methodologies and processes across product platforms s to ensure consistency and state-of-the-art Design History Files. The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization.

JOB RESPONSIBILITIES

• Integral member of product development team responsible for leading activities to ensure reliability of the design. Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target user population.
• In collaboration with product development, formalize new testing methodologies and approaches required to complete comprehensive reliability analyses of device designs. Lead/participate in verification and validation activities for newly developed test methods.
• Direct completion of specific product verification/validation testing and analyses required to satisfy both regulatory and internal requirements, including the preparation of quality plans and technical reports.
• Work directly with product development engineering to translate user requirements into design requirements down to the component level. Provide support for the identification of critical components and design features.
• Leads risk management activities throughout the product life cycle, including Hazard Analyses, DFMEAs, PFMEAs, and UFMEAs.
• Author, review, and/or approve DHF documentation (e.g., strategic planning, product specifications, design verification & validation activities, risk management activities, test method validations, protocols, reports, product transfer to operations, etc.).
• Provide quality oversight, review, and approval of qualification documentation and reports. Provide direction during technical and design review activities as a Design Quality SME. Provide Quality oversight of design controls activities. Review quality of work completed with the project team to ensure it meets project standards.
• Ensure the applicable development phase requirements are sufficiently fulfilled and documented within the DHF before allowing the project to proceed within the development process. Escalate and prevent the progression of product development, including release of clinical product, if warranted.
• Partner with Manufacturing and Manufacturing Quality during design transfer to ensure product DMR and knowledge transfer is complete and effective.
• Represent the company as the primary interfacing Design Quality SME with customers to ensure strong partnerships are established and implement solutions for any identified Quality concerns.
• Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve DFX capabilities. Provide guidance for development of manufacturing test/evaluation methods to assure process reliability requirements are attained.
• Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
• Completes risk analysis studies of new design and processes.
• May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
• Other duties as assigned.

BASIC SKILLS AND QUALIFICATIONS

• Minimum, Bachelor's Degree in engineering or science.
• Minimum, 5 years of related design control experience in medical device manufacturing.
• Working knowledge of Quality standards, i.e., QSR 21 CFR Part 820, ISO 13485, ISO 14971.
• Ability to influence R&D, Manufacturing and Engineering organizations regarding quality requirements and industry best practices.
• Experience leading design control methodology, design control meetings and phase gate processes.
• Excellent written and verbal communication skills. Ability to interact professionally with all organizational levels.
• Must be "hands on" when leading the development and validation of functional test methods.
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals.
• Ability to work independently, multi-task and thrive in fast-paced environment.

PREFERRED KNOWLEDGE, SKILLS AND ABILITIES:

• Master's Degree in engineering or science.
• 7 - 10 years of related design control experience in medical device manufacturing.
• ASQ CQA/CQE or equivalent certification.
• FDAS Class II/III medical device experience.
• Project management skills and proficiency in using MS office tools.
• Experience in mentoring junior engineers.