Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic leads the industry in digital mammography systems and offers the most advanced technology for breast imaging and breast biopsy. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for mennorrhagia, osteoporosis assessment, preterm birth screening, and mini C-arm for extremity imaging. For more information visit www.hologic.com

Job Posting Number - IRC4833

Job Title - Compliance Engineer

Organization Name - Corp., Engineering Services

Summary of Duties and Responsibilities

• Provides input during the design phase of product development to assure appropriate standards are applied.
• Schedules and coordinates compliance verification testing.
• Investigates and resolves issues related to product compliance to regulatory requirements.
• Reviews risk and hazard analysis documents during product development and product resolution.;
• Performs compliance assessment audits of Hologic products.
• Aid Design Engineering & Manufacturing Engineering in product and process problem resolution.
• Represents Regulatory Affairs/Quality Assurance in New Product Development programs as relates to safety compliance and risk and hazard analysis
• Member of the Sustaining Engineering taskforce
• Assists in interfacing with MDD notified body and technical file issues
• Helps prepare materials for submission to foreign government product registration
• Provides compliance support to other Hologic sites
• Complies with all QSr and ISO/EN procedures

Qualifications

• Computer literate
• Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations
• Excellent writing skills with ability to write compliance reports and detailed procedures
• Strong ability to effectively present information and respond to questions from senior management
• Excellent interpersonal skills

Education

BS in Electrical Engineering from a 4 year accredited University

Experience/Specialized Knowledge

• 6-10 years in the medical device industry

• Excellent working knowledge of international standards for electro-mechanical medical devices.

• Knowledge of product design for AC power distribution, signal processing and safety testing would be helpful

How to Apply

Candidates should apply on-line, www.hologic.com, click on “careers” keyword, “IRC4833”