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Senior Design Assurance Engineer

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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

 

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

 

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

 

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

 
Overview

A Design Assurance Engineer would work on a range of products in Hologic’s Breast Health Division on product systems that include digital mammography equipment and electronics.  You will work in a multi-disciplinary group, contributing to the design and development of Hologic’s innovative products focusing on design control including software development and system/software V&V.  Another plus: we work in the medical industry helping women to be free of debilitating gynecologic conditions – it’s good for the resume and good for the conscience!

 
Role 

Provide design assurance support in the development of medical device products, and facilitate the application of design controls and V&V system/software validation. Provide design assurance support to various manufacturing sites and contract manufacturers when design changes are required.

 
Essential Duties & Responsibilities
  • Actively participate on new product development projects ensuring that product design inputs are clear, concise, testable and appropriate and that design outputs confirm compliance to the design inputs.
  • Participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, within product teams and updates to existing product lines.
  • Review and approve design verification and validation test plans, protocols and reports. Ensure V&V results demonstrate compliance to medical device standards
  • Review test methods for quality of verification and validation of the method.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
  • Participate in continuous improvement of design control process and project management planning.

Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

 
  • Skilled in requirements analysis, including testable and measurable specifications
  • Experience with test methods and standards for the design, verification, and validation of medical device products
  • Skilled in test plan development and root cause failure analysis
  • Familiar with reliability analysis and test methods and test method validation
  • Working knowledge of IEC60601, IEC62366, EN62304
  • Good verbal (including presentation) and written communication skills, especially technical report writing
  • Ability to effectively work on project teams
  • Ability to appropriately assess written design and device documentation as the principle advocate for compliance
Preferred Skills/Qualifications:
  • Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Working knowledge with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
  • Skilled in statistical methods and design of experiments
  • Manufacturing engineering or manufacturing quality engineering experiences a plus
 
 
Education  
  • BS in an engineering discipline
 
Experience  
  • 3-5 years of engineering experience, preferably with V&V system/software validation
  • Strong working knowledge of verification and validation in a regulated industry
  • Experience with test methods and standards for the design, verification, and validation of medical device products
  • Skilled in test plan development and root cause failure analysis
 
 
Agency and Third Party Recruiter Notice:
 

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor

 
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