Design Quality Engineer II

CooperSurgical; Trumbull (CT); On-site; USD 78,000 - 100,000; Full time

Benefits offered by this job

Medical coverage

401(k) retirement plan

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Design Quality Engineer II to support product development and ongoing operations. You will apply design control principles and quality engineering techniques to ensure compliance with industry standards and regulatory requirements.

The role involves collaboration with cross-functional teams, inspections planning, risk management, and contributing to design input requirements based on historical issues and competitive insights. Travel up to 5% may be required.

Qualifications

• 3+ years of Quality Engineering experience in the medical device industry.
• Must understand FDA and medical device regulations.
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.

Responsibilities

• Actively represent Quality on product/process development teams.
• Support design verification, validation, specs, procedures, risk management and design reviews.
• Assist supplier tooling activities and PPAP processes.
• Contribute to root cause analysis and corrective actions for issues.
• Participate in design reviews and prototype testing; ensure manufacturability.
• Develop master test plans and validation methods for product and process testing.
• Identify and manage risk using FMEAs and other risk tools.
• Promote continuous improvement in design control activities across departments.

Skills

Analytical thinking

Communication

Team collaboration

Technical reading

Education

Bachelor’s Degree in Science or Engineering

Tools

Excel

Word

PowerPoint

Job description

Job Description The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem-solving activities for product and process improvements, while collaborating with cross‑functional teams and providing guidance when appropriate.

Job Description The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem‑solving activities for product and process improvements, while collaborating with cross‑functional teams and providing guidance when appropriate.

Responsibilities

• Quality Representation
  • Actively represent Quality function on product/process development teams.
  • Support engineering teams to ensure design control requirements are met effectively, including design verification, validation, specifications, procedures, risk management, and design reviews.
• Supplier Engagement
  • Support supplier tooling activities to help ensure components are qualified on time, including use of PPAP tools.
  • Participate in supplier selection activities and specification reviews to help ensure purchased components meet requirements.
  • Collaborate with Engineering to define quality characteristics and inspection plans for components, subassemblies, and finished devices.
• CAPAs/Non conformances
  • Participate in investigations of product and process issues; contribute to root cause analysis and corrective actions.
  • Support evaluation and disposition of nonconforming materials used in development, pilot, or clinical builds in accordance with quality system requirements.
• Design
  • Participate in design reviews to evaluate designs and provide quality-related feedback.
  • Contribute to early stages of product development, including prototype evaluation, testing, and cross‑functional collaboration.
  • Provide input to design and manufacturing documentation (e.g., specifications, drawings, inspection procedures) to support manufacturability and testability.
  • Contribute to development of design input requirements based on prior product knowledge, historical issues, and competitive insights.
• V&V
  • Support development of the master test plans (I.E. trace matrix, VMP...). that encompass design verification, design validation and process validation activities.
  • Contribute to development, evaluation, and validation of product and process test methods.
  • Review test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Risk
  • Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. 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
  • Identifies and contributes to improvements across all cross functional departments.
  • Promotes 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 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.
  • Support 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.

Qualifications

QUALIFICATIONS

Knowledge, Skills and Abilities:

• Working knowledge of applicable laws and regulations.
• 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
• Effective oral, presentation and technical writing skills
• Demonstrated ability to support decision making within quality engineering responsibilities
• Experience collaborating with cross‑functional teams in a medical device development environment.
• Strong analytical and problem‑solving skills with acute attention to detail.
• Good communication and interpersonal skills.

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:

• 3+ 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 preferred.

Education:

• Bachelor’s Degree or higher in Science or Engineering (or related field).

Our Benefits:

As an employee of CooperSurgical, you'll 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 www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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 pay for this role is between $78,420 - $100,000.00 annually. The actual base pay includes 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.