Senior Engineer Regulatory (Medical Device Product Compliance Engineer, Codes and Standards Engineer, Safety Engineer) - Batesville - job 1197296

Hill-Rom

Date: 09/12/2021

City: Batesville, Indiana

Employment type: Full-time


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:


The Senior Engineer Regulatory will work with New Product Development (NPD) Teams and Sustaining Engineering to realize compliant products based on national and international codes. This position also has the responsibility for design change surveillance and general technical file maintenance for the life of the products.


REPORTING RELATIONSHIPS:


The Senior Engineer Regulatory is an individual contributor (no direct reports) is a member of the global Regulatory Affairs team and reports directly to the Senior Codes & Standards Manager.


LOCATION:


Batesville, IN is the primary location for this role; however, 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:



  • May have some supervisory responsibilities as required based on projects

  • Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.

  • Define compliance strategies to certify and list products.

  • Provide technical review of product to ensure alignment with national and international codes.

  • Help maintain and sustain the product technical files for the production life of the products.

  • Assist product development teams in applying and understanding design standards and codes.

  • Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.

  • Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.

  • Maintain necessary technical and certification files for agency review and approval, as needed.


EDUCATION AND EXPERIENCE:



  • BS Degree in Electrical or Mechanical Engineering or equivalent experience.

  • Minimum of 5 years' experience in the medical device industry preferred.

  • Minimum of 5 years' experience in Compliance Engineering equivalent to working with Notified Bodies.

  • Self-motivated with high performance standards.

  • Experience working in a regulated industry.

  • Excellent written and oral communication skills.

  • Previous Design Compliance Experience and standards preferred.

  • Experience working in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.

  • Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, lEC, VDE, CSA).

  • Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, and EN 60601-2-52





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