Design Assurance Engineer in Marlborough Massachusetts United States

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Summary of Duties and Responsibilities Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic''s success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. *Role * Provide design assurance support in design and development of medical device products, and facilitate the application of design controls. Provide support to various manufacturing sites and contract manufacturers. **Essential Duties & Responsibilities Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, biocompatibility, sterility and conformance to product requirements. 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. Ensure successful transfer of new products to production facility Review production processes for quality of verification and validation methods Review and approve verification and validation test plans. Ensure verification results demonstrate compliance to medical device standards Lead project teams with verification/validation statistical methods and design controls Participate in product risk assessment efforts within product teams and updates to existing product lines 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. Skills/Competencies: Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive 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 Skilled in statistical methods statistical process control, sampling plans, gauge R&R;, and design of experiments Good verbal (including presentation) and written communication skills, especially technical report writing Ability to effectively work on project teams Preferred Skills/Qualifications: Familiar with reliability analysis and test methods and test method validation Familiar with ISO 14971. Experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP Manufacturing engineering or manufacturing quality engineering experiences a plus Other Skills: Spanish proficiency desirable Education BS in an engineering discipline Experience 2-5 years of design assurance or relevant quality engineering experience Specialized Knowledge Additional Details **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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