Senior Software Validation Engineer

National Society for Black Engineers; Trumbull (CT); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player in women's healthcare is seeking a Senior Software Validation Engineer to join their team in Trumbull, Connecticut. This pivotal role involves ensuring compliance with industry standards while supporting software design and implementation for innovative medical devices. The ideal candidate will have a strong background in quality engineering and medical device software validation, with a passion for improving family outcomes. You'll collaborate with cross-functional teams, mentor peers, and lead risk management efforts, all while contributing to the development of groundbreaking solutions in women's health. If you are a self-motivated leader with a commitment to quality and compliance, this opportunity is perfect for you.

Benefits

Medical Coverage

401(k)

Parental Leave

Fertility Benefits

Paid Time Off

Qualifications

• 10+ years of experience in medical device software validation.
• Knowledge of regulatory standards like ISO 13485, ISO 14971, IEC 62304.

Responsibilities

• Lead investigations into complex product and software issues.
• Guide engineering staff on design control requirements.
• Develop master test plans covering software verification and validation.

Skills

Software Validation

Quality Engineering

Regulatory Compliance

Risk Management

Technical Writing

Interpersonal Skills

Project Management

Education

Bachelor's degree in Science or Engineering

Certification in Quality Engineering (ASQ CQE)

Tools

Microsoft Office Suite

Job description

JOB DESCRIPTION

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to supporting women, babies, and families during crucial healthcare moments. We innovate in assisted reproductive technology and genomic solutions to assist ART professionals and improve family outcomes. We offer over 600 medical devices for women's healthcare, including testing and treatment options.

As a subsidiary of CooperCompanies (Nasdaq: COO), headquartered in Trumbull, CT, CooperSurgical develops and markets products and services for women’s health care providers. Visit www.coopersurgical.com for more information.

RESPONSIBILITIES

The Senior Software Validation Engineer will be based on-site in Trumbull, Connecticut, reporting to the Quality Engineering department. The role involves supporting software design and implementation for new product development and sustaining projects, ensuring compliance with industry standards, regulations, and customer requirements.

Essential Functions & Accountabilities:

1. Represent the Quality function in product, process, and software development teams.
2. Mentor team members in Design Quality Engineering methodologies.
3. Guide engineering staff on design control requirements, including verification, validation, risk management, and design review.
4. Lead investigations into complex product and software issues, managing corrective actions.
5. Participate in design reviews and evaluate designs for alternative solutions.
6. Review system, software, and cybersecurity requirements, including code inspections.
7. Engage in early product development stages, including physician interactions and prototype testing.
8. Manage risks using FMEAs and other tools, leading risk management efforts for software design and cybersecurity.
9. Develop master test plans covering software verification and validation.
10. Create and validate software and process test methods, ensuring regulatory compliance.
11. Contribute to documentation, including specifications, drawings, and procedures.
12. Provide input based on experience with similar products and issues.
13. Promote continuous improvement in software design control activities and quality tools.
14. Participate in supplier selection and review processes for software components.
15. Ensure compliance with FDA and international regulations, maintaining current knowledge of standards.
16. Represent CooperSurgical in audits and regulatory interactions.
17. Perform other duties as assigned.

Travel: Up to 5% for business purposes.

QUALIFICATIONS

• Bachelor’s degree or higher in Science, Engineering, or related field.
• Certification in Quality Engineering (ASQ CQE preferred).
• 10+ years of experience in medical device software validation.
• Experience with medical devices, especially in women’s health, preferred.
• Knowledge of regulatory standards like ISO 13485, ISO 14971, IEC 62304; cybersecurity experience is a plus.
• Proficiency in Microsoft Office Suite; advanced skills preferred.
• Strong technical reading and writing skills in English.
• Self-motivated team player with excellent interpersonal, organizational, and project management skills.
• Proven leadership in cross-functional teams and excellent problem-solving skills.

We offer a comprehensive compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and other perks. Visit www.coopersurgical.com to learn more.

All candidate submissions from agencies must be made through our approved channels; unsolicited resumes will be the property of CooperSurgical. We are committed to equal employment opportunity regardless of race, gender, or background.