Design Quality Engineer II

CooperCompanies • $88K — $105K *
Trumbull, CT 06611In-Person
Healthcare
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 3+ years of experience in Quality Engineering within the medical device industry.
  • Bachelor's Degree or higher in Science or Engineering (or related field).
  • Knowledge of applicable laws and regulations in medical device development.
  • Intermediate to advanced proficiency in Excel, Word, and PowerPoint.
  • Strong analytical, problem-solving, and communication skills.

Responsibilities

  • Represent the Quality function on product and process development teams.
  • Support engineering teams in meeting design control requirements, including verification and validation.
  • Engage with suppliers to ensure timely qualification of components through PPAP tools.
  • Investigate product and process issues, contributing to root cause analysis and corrective actions.
  • Participate in design reviews and provide quality feedback on designs.
  • Contribute to development and validation of test plans and protocols for regulatory compliance.
  • Identify and manage risks using FMEAs and other tools throughout the development process.

Benefits

  • Opportunity for cross-functional collaboration with diverse teams.
  • Engagement in the entire product development lifecycle from design to manufacturing.
  • Contribution to significant advancements in women's health through technical expertise.
  • Exposure to regulatory processes and compliance standards in medical device industries.
Full 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.

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).

About CooperCompanies

CooperCompanies Careers

Joining CooperCompanies presents an unparalleled opportunity to become part of a global team dedicated to fostering innovation, leadership, and professional growth. As a leading entity in the medical sector, CooperCompanies offers a range of job opportunities that cater to a diverse set of skills and experiences.

Explore Career Opportunities

CooperCompanies is actively hiring and continuously seeks passionate, creative, and solution-driven team players. Explore open positions that align with your professional interests and expertise. Each position at CooperCompanies is a chance to thrive in a culture that values diversity and leadership.

Professional Growth and Development

At CooperCompanies, career growth is a priority. The company supports professional development through comprehensive training programs, including leadership development and diversity training. These initiatives ensure that every team member has the tools and knowledge to advance their career.

Innovation and Team Collaboration

Innovation is at the heart of CooperCompanies. The team collaborates on projects that push the boundaries of technology and service in the medical field. Working at CooperCompanies means joining forces with some of the brightest minds in the industry to deliver solutions that truly make a difference.

Internship Programs

For those starting their career journey, CooperCompanies offers internship programs that provide a robust introduction to the medical industry. Internships are a pivotal step for gaining real-world experience, enhancing your resume, and building a professional network.

Benefits and Company Culture

CooperCompanies is committed to supporting its employees with exceptional benefits and a nurturing work environment that promotes a balance of professional and personal growth. The company culture is built on a foundation of respect, inclusion, and collaboration, making it a prime workplace for individuals from all walks of life.

Networking and Industry Leadership

Employees at CooperCompanies are encouraged to engage in networking opportunities within and beyond the company. This connectivity is vital for fostering relationships that can lead to innovative collaborations and career advancement.

Applying for a Position

To apply for a position at CooperCompanies, candidates should prepare their resume to highlight relevant experience and skills. The interview process is designed to assess fit both for the candidate and the company, ensuring alignment with CooperCompanies' core values and business objectives.

Stay Connected with CooperCompanies Careers

Keep up to date with the latest job opportunities, company news, and industry insights by subscribing to the CooperCompanies careers newsletter. Discover the exciting and rewarding career opportunities that await at CooperCompanies.

Search CooperCompanies Jobs

Interested candidates are invited to search current job listings and find positions that match their skills and career aspirations. Join CooperCompanies and be part of a team that is dedicated to making a significant impact in the healthcare industry.
Learn more about CooperCompanies
Industry
Healthcare
* Ladders Estimates

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