Job DescriptionThe Senior Staff Design Quality Engineer (DQE) will be a senior technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. This position will provide advanced expertise in implementing and maintaining robust quality management systems, leading design control and risk management activities across multiple projects, executing and/or defining plans for executing strategic goals established by leadership, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.
This position operates as a recognized subject-matter expert and technical authority in one or more specified DQE domains, influencing quality practices across projects/programs and leading the execution of strategic initiatives in alignment with organizational quality objectives.
The Senior Staff Design Quality Engineer will provide technical leadership to ensure the successful development of Cooper products and ongoing operational support. This individual will be expected to apply his/her knowledge of design controls, risk management, verification and validation principles and quality engineering techniques to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
The Senior Staff Design Quality Engineer provides expert guidance on scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams, and provides mentorship (including coaching, reviewing, training, delegating work) to peers, leads less experienced DQEs, and cross-functional engineering teams.
ResponsibilitiesEssential Functions & Accountabilities:- Design Quality Leadership
- Represent the Quality function on product/process development teams.
- Mentor other discipline as needed in the Quality Engineering methodology.
- Ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes. May serve as independent reviewer during design reviews, or conduct DHF audits, as required.
- Owner/Approver of one or more processes within the scope of Design Quality.
- Supplier Engagement
- Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper's specifications.
- Manage supplier to ensure all quality and manufacturing elements supporting final components are qualified at the supplier and on time utilizing PPAP tool.
- Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
- Review/Approval of PPAP. May serve as PPAP lead.
- CAPAs/Non conformances/HHE
- Lead or Participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
- Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds.
- Conducts or supports health risk assessments in support of the Health Hazard Evaluation, Reporting or Recall processes.
- Design
- Participate in design reviews to evaluate designs, ensure DHF completeness and accuracy, and to help identify alternative design solutions.
- Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
- Contributes to design input requirements as a result of risk analysis, from experience with previously reported problems, Cooper's products, competitive devices and/or other similar products.
- Approves deviations and design changes, conducts impact assessments, and defines/approves change implementation plans.
- Verification & Validation
- Participate in the development of the master test plans (I.E. trace matrix, VMP....) that encompass design verification, design validation and process validation activities.
- Creation, evaluation, and validation of product and process test methods.
- Apply statistical techniques in sample size determination and data analysis.
- Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Risk Management
- Defines risk management strategy throughout product lifecycle including construction of the Risk Management File, Risk Management Planning, and benefit-risk evaluations.
- Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools, ensuring effective integration of risk activities throughout product realization process and feedback into design inputs, improvements and maintenance of the product risk profile. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
- Process Improvement and Project Management
- Leads strategic initiatives as aligned with organizational quality objectives. May manage a crossfunctional team to execute plans.
- Actively identifies and leads opportunities for improvements across all cross functional departments.
- Promotes continuous improvement in design control and risk management activities and use of quality tools with design team and other departments.
- Regulatory
- Comply with applicable FDA and international regulatory laws/standards and the Cooper's Code of Conduct.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. Implement new or updated standards into existing procedures.
- Represent Cooper as needed in FDA, notified body, internal, and other audits.
- Technical Mentorship
- Serve as a technical mentor to QEs, providing guidance on complex quality engineering topics.
- Promote continuous improvement and consistent application of design quality tools and methodologies.
- Acts as a recognized subject matter expert in one or more DQE domains across the organization.
- Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data.
- Perform other duties as assigned.
Travel:This position may require 10-20% domestic and/or international travel.
QualificationsQualificationsKnowledge, Skills and Abilities:- Advanced working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR.
- Demonstrated knowledge in the application of medical device design controls, verification/validation, risk management principles per ISO 14971, and the use of risk assessment tools such as FMEA, Hazard Analysis.
- Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
- Ability to read and understand highly technical material.
- Proficient in reading and writing in English
- Self-motivated and committed to a team approach
- Strong interpersonal, organizational and project management skills. Ability and experience interfacing with senior leadership and external stakeholders.
- Strong oral, presentation and technical writing skills
- Demonstrated skills in decision making, problem solving, negotiation, and influencing without direct authority preferably across a broad spectrum of Quality Engineering responsibilities
- Proven experience leading cross-functional teams in a medical device development environment.
- Experience with Change Control, Non-conformance, Deviation, Complaints, HHEs and/or CAPAs.
- Strong analytical and problem-solving skills with acute attention to detail.
- Excellent communication and interpersonal skills.
- Knowledge in application of IEC 62304 a plus.
- Knowledge in one or more IEC 60601, ISO 10993, IEC 62366, ISO 11607, ISO 11137 or ISO 11135 preferred.
- Knowledge in application of biocompatibility and/or sterilization standards for medical devices.
Work Environment:- Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.
Experience:- 10+ years experience in Quality Engineering in the medical device industry with a Bachelors Degree, or 8+ years with a Masters Degree, Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
- Hands-on experience in medical device product development in concept through commercialization, and/or leading design changes, improvements or remediation initiatives in sustaining operations. Knowledge in women's health a plus.
- Hands on experience creating and executing testing strategies for biocompatibility per ISO 10993.
- Experience working with resorbable or biomaterial-based implants or injectables or mediapreferred.
Education:- Bachelor's Degree or higher in Science or Engineering (or related field).
- Professional certifications in Quality Engineering (ASQ Certified Quality Engineer), lean, six sigma, DFSS, project management preferred.
