Staff Design Quality Engineer

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies(Nasdaq: COO) were driven by a unified purpose of helping people experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location:Trumbull CT or Livingston NJ (on-site)

Scope:

The Staff Design Quality Engineer is an experienced technical individual contributor responsible for ensuring the safety effectiveness and compliance of medical devices throughout the design and development lifecycle. This position provides technical expertise in implementing and maintaining quality management system requirements leading design control and risk management activities for product development projects and supporting the execution of quality and business objectives established by leadership. The Staff DQE collaborates with internal and external cross-functional teams to deliver high-quality medical device solutions that meet regulatory customer and business requirements.

This position serves as a key quality representative on product development and sustaining engineering projects providing guidance on quality engineering principles design controls risk management verification and validation activities and supplier quality processes. The Staff DQE influences project-level quality decisions drives compliance to applicable standards and regulations and supports continuous improvement initiatives within the organization.

Job Summary:

The Staff Design Quality Engineer provides technical leadership and quality engineering support to ensure the successful development transfer and ongoing support of Cooper products. This individual applies knowledge of design controls risk management verification and validation principles quality engineering techniques and supplier quality processes including supplier collaboration and PPAP execution to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards regulatory requirements and customer expectations.

The Staff Design Quality Engineer provides guidance on scientific and technical data related to product design manufacturing processes and product testing to support quality and compliance objectives. This position partners cross-functionally with R&D Operations Regulatory Supplier Quality and Clinical teams. The Staff DQE provides guidance and knowledge sharing to peers and less experienced engineers contributes to problem-solving activities and continuous improvement efforts and supports the successful execution of product development and sustaining engineering programs.

• 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 Coopers specifications.
  • Specifies quality characteristics and inspection plans for components subassemblies and finished devices with the Engineering Team.
  • Lead and actively support supplier quality activities including close collaboration with external suppliers to ensure components assemblies and processes meet design specifications quality requirements and applicable regulatory standards.
  • Demonstrate strong working knowledge and handson experience with Production Part Approval Process (PPAP) execution including review and approval of supplier deliverables such as PFMEAs control plans process flow diagrams capability studies and dimensional layouts
  • Ensure that supplierprovided PPAP and qualification documentation is complete accurate and aligned with design intent risk management outputs and validation requirements.
  • Partner with Supply Chain Engineering Manufacturing and Regulatory teams to ensure suppliers are properly qualified and able to consistently deliver productionrepresentative components suitable for clinical and commercial use.
  • Assess supplier readiness and performance through technical reviews audits and data analysis identifying gaps and driving corrective actions as needed to mitigate quality and compliance risks.
  • Act as a key quality decisionmaker providing clear recommendations based on technical data supplier capability and regulatory expectations to support safe effective and compliant products.
• 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.
• Design
  • Participate in design reviews to evaluate designs 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 from experience with previously reported problems Coopers products competitive devices and/or other similar products.
  • Approves deviations and design changes conducts impact assessments and defines/approves 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.
  • 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 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
  • 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 Coopers 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.
• 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 10-15% domestic and/or international travel.

Knowledge 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 Knowledge in application of IEC 62304 preferred.
• Knowledge in one or more ISO 10993 IEC 62366 ISO 11607 ISO 11137 or ISO 11135 preferred.

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:

• 7 years or more experience in Quality Engineering in the medical device industry. Experience in related engineering areas e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
• Handson experience in medical device product development in concept through commercialization and/or leading design changes improvements or remediation initiatives in sustaining operations. Knowledge in womens health a plus.

Education:

• Bachelors Degree or higher in Science or Engineering (or related field)
• Certification in Quality Engineering (ASQ Certified Quality Engineer)

Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us at to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between $120000.00 - $150000.00. The actual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.