Principal Software Validation Engineer

About CooperSurgical

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

The Senior Software Validation Engineer will be a remote role with a reporting structure into Trumbull, Connecticut and will be responsible for providing software design and implementation support for Quality Engineering in New Product Development and Sustaining projects. This position will provide Quality Engineering support and leadership to ensure the successful software development within Cooper products and ongoing operational support.  This individual will be expected to apply his/her knowledge of software design control principles to positively influence software development efforts as needed.  In parallel, this person shall also ensure the product software is developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. 

• Actively represent Quality function on product/process/software development teams.
• Mentor other discipline as need in the Design Quality Engineering methodology.
• Provide guidance to Engineering staff and other personnel and ensures that 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.
• Lead or Participate in the investigation of complex product & software problems. Identify and manage corrective actions resulting from problem investigations.
• 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, software validation and prototype testing.
• 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.
• Participate in the development of master test plans that encompass software design verification, software design validation.
• Creation, evaluation, and validation of software, product and process test methods.
• Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Provides input to software design and manufacturing documentation including software specification, material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Contributes to software design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
• Promotes continuous improvement in software design control activities and use of quality tools with design team.
• Participates in OTS software design supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.
• 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 software development and release of medical devices & software.
• Represent Cooper as needed in FDA, notified body, internal, and other audits.
• Other duties as assigned or required.

• Bachelor’s Degree or higher in Science or Engineering (or related field)
• Certification in Quality Engineering (ASQ Certified Quality Engineer)
• 10+ years or more experience with medical device software validation in the medical device industry. 
• Experience in medical devices, with knowledge in women’s health is preferred.
• Knowledge of applicable laws and regulations.
• Intermediate skill in the use of E