Design Quality Engineer Senior

CooperSurgical is a leading fertility and women’s 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), we're driven by a unified purpose of helping people experience life’s 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 women’s 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 www.coopersurgical.com.

• Quality Representation
  • Actively represent Quality function on product/process development teams.
  • Mentor other disciplines as needed in the Quality Engineering methodology.
  • Provide guidance to Engineering staff and other personnel ensuring design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
• Supplier Engagement
  • Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool.
  • Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with Engineering Team.
• CAPAs/Non conformances
  • Lead or participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
  • Evaluate and disposition nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
• Design
  • Participate in design reviews to evaluate designs and 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.
  • Provide 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.
  • Contribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
• V&V
  • 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.
  • Evaluate test protocols and reports to ensure testing is sufficient to meet regulatory requirements and quality objectives.
• Risk
  • Identify and manage risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design and management team on managing product and process risks.
• Process Improvement
  • Actively identify and lead opportunities for improvements across all cross functional departments.
  • Promote continuous improvement in design control activities and use of quality tools with design team and other departments.
• Regulatory
  • Comply with applicable FDA and international regulatory laws/standards and Cooper’s Code of Conduct.
  • Maintain knowledge of current regulatory requirements and standards as they pertain to development and release of medical devices.
  • Represent Cooper as needed in FDA, notified body, internal, and other audits.
• Perform other duties as assigned.

Travel:

This position may require 0-5% domestic and/or international travel.

Knowledge, Skills and Abilities:

• Knowledge of applicable laws and regulations.
• Intermediate skills in Excel, Word and PowerPoint.Advanced skills preferred.
• Ability to read and understand highly technical material.
• Proficient in reading and writing in English.
• Self-motivated and committed to a team approach.
• Knowledge of ISO 13485 and ISO 14971
• Strong interpersonal, organizational and project management skills.
• Strong oral, presentation and technical writing skills.
• Strong decision-making skills, preferably across a broad spectrum of Quality Engineering responsibilities.
• Experience leading cross-functional teams in a medical device development environment.
• Strong analytical and problem-solving skills with attention to detail. Knowledge of statistics and how to apply, evaluate, and provide recommendations from data.

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:

• 5+ years 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.
• Experience in medical devices, with knowledge in women’s health is preferred.

Education:

• Bachelor’s Degree or higher in Science or Engineering (or related field).
• Certification in Quality Engineering (ASQ Certified Quality Engineer).