Manufacturing Engineer 3

Company: Hologic
Location: Danbury
Posted on: January 12, 2021

Job Description:

Our PURPOSE---to enable healthier lives everywhere, every day---is driven by a PASSION to become global champions for women---s health. We succeed by fulfilling our PROMISE to bring The Science of Sure-- to life through product quality, clinical differentiation, customer relationships and our team---s talent and engagement. Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this end, we offer clinically proven products designed to detect, diagnose and treat disease and other health conditions that primarily affect women---earlier and more accurately than ever to provide ever greater certainty and peace of mind. This focus has fueled our long track record of innovative medical breakthroughs across many therapeutic areas---breast health, cervical health, body composition, gynecologic health, perinatal health, skeletal health and sexual health---touching the lives of more than 230 million women around the world every year. In fact, as global champions for women---s health, no company in the world has done more to fight cervical and breast cancer than Hologic---and we will continue to challenge ourselves to ensure that future generations of women have access to our life-saving innovations. Of course, none of this would be possible without the talent and passion of our employees. Together, our collective expertise and dedication to develop and market robust, science-based certainty sustain a pipeline of exceptional solutions that respond to the unmet health and wellness needs of women, families and communities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates sustainable global financial growth from which success and prosperity for our company, employees and investors naturally follow. Job Summary: We are looking for a talented Manufacturing Engineer to oversee and improve manufacturing processes for medical equipment. The Manufacturing Engineer's responsibilities include identifying areas for improvement, maintaining high levels of manufacturing and product quality, improving products and processes, and conformance with regulatory standards. A successful Manufacturing Engineer should be able to work effectively within a team and apply knowledge of product design, fabrication, assembly, tooling, testing, and materials. They should also have a drive for standardizing processes to remove variation and prevent errors, along with the belief that processes of today must be challenged and improved for tomorrow. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Ability to understand design requirements and be able to create a manufacturing plan Hands on knowledge of creating process flowcharts, PFMEA & Process Control plans.Facilitate the transfer of design changes from design engineering to manufacturing.Performs root cause analysis and recommends corrective actions in response to manufacturing issues. Continuously work to improve manufacturing methods, efficiency and product quality.Specify and provide all necessary tools, equipment, fixtures, and facilities required for assigned product line.Assists in maintaining existing test fixtures and update work instructions as required.Manage Software validation and release for production.Develop and validate processes for manufacturing as per FDA guidelines. Hands on experience of process validations including IQ,OQ,PQ.Define and develop assembly and test methods for assigned product line. Assure that work instructions and drawings are created when necessary.Monitor quality reports and field performance of assigned product line, identify trends, investigate problems and implement corrective actions.Maintain product sequence and routingsServe as interface for key subcontractors. Provide training and assistance, as necessary. Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls.Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.Lifting/moving and carrying products weighing up to 40 pounds.Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.Potential Exposure to hazardous chemicals or other materials.Safety Shoes with Impact and Compression Protection Must be worn in designated areas.May work with or around high voltage and radiation generating equipment. Education: B.S. Mechanical, Manufacturing, Software, Industrial Engineering Also A.S. degree with 6 years of related work experience Experience: Minimum two years--- experience in Manufacturing Engineering and/or Similar Medical Device Manufacturing experience preferred Skills: Change Management including verification and validation. Security Patch and Software validation. Understanding & hands on application of Lean Manufacturing principles preferred. Ability to manage projects. Experience with computer-aided design preferred. Labview experience is preferred. Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V) 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.

Keywords: Hologic, Danbury , Manufacturing Engineer 3, Other , Danbury, Connecticut