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Senior Software Quality Assurance Engineer, New Product Development (medical device or other regulated technical industry (e.g., aerospace, automotive, defense)

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Título Oferta:
Senior Software Quality Assurance Engineer, New Product Development (medical device or other regulated technical industry (e.g., aerospace, automotive, defense)
Empresa:
by dejobs.org
Estado:
Monterrey
Texto Oferta:
**Description** Hillrom is a $2.9B global medical technology company with more than 10,000 employees worldwide. Every day, around the world, we enhance outcomes for patients and their caregivers. Our vision is all about Advancing Connecting Care from the doctor’s office, to the hospital, or the comfort of home. We focus on solutions that improve clinical and economic outcomes in five core areas: accelerating patient recovery, simplifying clinical communication and collaboration, enabling earlier diagnosis and treatment, optimizing surgical efficiency and safety, and shifting care closer to home. Five values are the foundation of our corporate culture guiding us to enhance outcomes for patients and caregivers. Our values are Respect, Responsiveness, Results, Integrity and Fun. and are grounded in our six commitments: Patients and Caregivers are our Passion. Quality Matters in All We Do. Financial Discipline Drives Value. Innovation Fuels Our Growth. Continuous Innovation Creates Simplicity. and People Inspired to Win Together. These drivers guide Hillrom employees who play a critical role within the organization to drive and achieve our goals. One of Hillrom’s values is fun. That shows up in many ways throughout the year. You can enjoy summer hours in June, July and August with paid Friday afternoons off! Or put your passion in volunteering during the month October when we offer one half day of paid time off through Hillrom For Humanity. These are just a few examples of what makes Hillrom special. Employee Resource Groups (ERG) are essential components of Hillrom’s commitment to drive inclusion to unify who we are and our purpose. They allow us to capitalize on the resources of Hillrom employees and support Hillrom’s commitment to Diversity, Equity, Inclusion, Belonging. Our 7 ERGs foster an environment of belonging where all our voices matter. True innovation is driven by the convergence of many opinions, skill sets, and life experience which is why Diversity, Equity, Inclusion and Belonging isn’t just good for society it’s good business. Hillrom is focused on building a workforce that represents our customers and our world while ensuring that all associates feels like they truly belong. We continue to evaluate progress in several areas of hiring, retaining talent from underrepresented groups which include ethnic minorities, Women, Veterans, Individuals with Disabilities and the LGBTQIA. Our commitment to Diversity, Inclusion and Belonging is part of our fabric. THE ROLE: Hillrom Patient Support Systems (PSS) business unit is focused on accelerating patient recovery. Clear visibility into patient status can help identify issues sooner to avoid common risks and enable faster treatment and recovery time. We help care teams stay connected with innovative solutions for patient monitoring (patient status and vitals monitoring products provide real-time patient status and connect to EMR systems), safe patient handling and transport (patient lifts and stretchers focus on both caregiver and patient safety), non-invasive respiratory therapy, and smart beds and surfaces (beds and surfaces have become connected medical devices designed to help deliver therapy and enhance safety). PSS business unit understands the demands that healthcare executives, clinicians and operations teams face each day. Patients present with a broad array of conditions, while staff-to-patient ratios and the demands of documentation can leave caregivers feeling overextended. To manage these challenges, caregivers need the right products and programs to deliver safe, effective care that enhances the patient´s experience and possibly reduces costs. The PSS Product Portfolio meet customers´ and patients´ needs in acute care hospitals, long term care facilities and in the home and include Bed Frames and Surfaces, Bariatric Solutions, Clinical Workflow Solutions, Patient Handling Solutions, Healthcare Furniture and Design Construction Services. As a member of the R D project team, the Senior Software Quality Assurance Engineer - New Product Development (NPD) contributes to the development of complex medical device projects ensuring the highest quality and product safety. S/he is responsible for participating in various design assurance initiatives to improve the overall quality of new product designs and the company’s regulatory compliance profile, this role will frequently interact with and influence project team members and project team leaders. this Sr Engineer is jointly responsible for the Design Development Plan and/or the Quality Plan and its deliverables to meet quality, schedule and budget goals on complex New Product Development (NPD) and sustaining projects. This role will utilize his/her technical skills in communicating and influencing project and functional leadership on assigned project/s. In addition, this Sr. Engineer will support the R D project team through the NPD and sustaining engineering processes at the Hillrom Batesville Business site. REPORTING RELATIONSHIPS: The Senior Software Quality Assurance Engineer reports to the Sr. Manager of Design Assurance. Furthermore, S/he will work collaboratively with the R D teams. LOCATION: The role is located at any of our locations in Chicago, IL, Batesville, Indiana, Cary, North Carolina, Sarasota, Florida, Jupiter, Florida, Irvine, California, Doral, Florida, Acton Massachusetts, Milwaukee, Wisconsin, St. Paul, Minnesota, Monterrey, Mexico or Tijuana, Mexico. Hillrom’s hybrid work model enables employees to determine with their managers which days they can work remotely. It’s just one of the many ways Hillrom’s culture fosters quicker decisions, collaboration, connectivity, career development and work-life balance. BASIC FUNCTION AND PRINCIPAL RESPONSIBILITIES: - Responsible for all design assurance functions as a core team member on NPD teams, ensuring the team complies with all portions of design control and related quality system elements - Prepare and manage all design assurance required NPD deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements - Ensure product development activities related to verification and validation are fully compliant with the quality system procedures - Assist in identification and mitigation of product or process-related risks - Function as the design assurance lead and owner on PSS NPD projects; interacting frequently and regularly with project team members and leaders - Perform and influence in cross-functional team environments and utilize effective interpersonal skills - Ensure project meets all applicable internal and external requirements to avoid/minimize quality/safety/compliance risks **Qualifications** + B.S. in Engineering or other technical degree required, preferably Computer Science/Engineering or Electronics/Electrical Engineering. + 2 years’ experience in quality assurance; product design experience may be considered in lieu of quality assurance experience; knowledge of AAMI 62304 standard is valuable + 5 years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role or in a role closely connected to design/development/quality; software quality in the medical device industry highly desired + Knowledge of software development lifecycle processes and standards as well as tools and methods for medical devices and/or other regulated industries + Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards + Knowledge of 21 CFR 820.30, ISO13485, IEC62304; EN ISO 14971:2012; safety by design; risk management structure desirable. + Demonstrated ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills; ability to lead other engineers as needed + High degree of autonomy and independent decision making required + Demonstrated skills to balance tactical and strategic goals + Ability to plan and manage multiple complex projects with budgets **Job:** Quality **Primary Location:** United States-Illinois-Chicago, IL **Other Locations:** United States-Indiana-Batesville, Mexico-Baja California Norte-Tijuana, United States-Minnesota-St. Paul, United States-Florida-Jupiter, United States-Massachusetts-Acton, Mexico-Monterrey, United States-California-Irvine, United States-Wisconsin-Milwaukee, United States-Florida-Miami, United States-Florida-Sarasota, United States-North Carolina-Cary **Schedule** Full-time **Travel** Yes, 10 % of the Time **Posting Entity** Hillrom **Req ID:** 21122888
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