Baxter Sr Principal Compliance Engineer in Sweden, Sweden
Senior Principal Compliance Engineer
Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters .
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The Job Baxter Healthcare International is a world leader in Medical Products used in all markets. Our continued growth and success have created an outstanding opportunity for a Compliance Engineer.
This professional will be responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs. This includes working with cross-functional product development partners to develop compliance strategy, identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products. This role will be responsible for development and maintaining relationships with test houses and certification agencies. This position requires candidates to maintain their knowledge of current standards and developing or changing standards that affect Baxter products.
Some of the activities will include: * Partner with design engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve design and product safety issues
Consult with program teams on product certification strategy and compliance issues to develop the certification strategy, compliance plan, and compliance long-term roadmaps for products and product platforms.
Will work under the direction of the Product Certification and Engineering Services Manager to ensure compliance of Baxter Healthcare products with standards requirements. Will also support efforts to comply with environmental regulations.
Interact with program management, R&D teams, manufacturing sites and service locations to ensure that Baxter Healthcare products comply with product certification requirements for their intended use markets (domestic and international).
Keep abreast of changes to product standards and regulations affecting medical products.
Travel will be required to perform job duties.
Supervise the conduct of certification tests.
Schedule compliance testing for Baxter Healthcare products at onsite test facility and at external test laboratories.
Submit documentation to regulatory authorities in coordination with Baxter Regulatory Affairs personnel to obtain product certifications (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand)
Develop standards strategy for Baxter programs that enable market access of medical devices in the intended markets for products
Responsibilities and Duties
Supervise and perform testing on products at on-site and off-site test facilities
Keep abreast of changes to regulations impacting Baxter device products through research and training.
Prepare product qualification submittal documentation to regulatory agencies
Ensure that lab test procedures and process comply with Baxter Healthcare policies, and international standards and quality management requirements.
Support Baxter Healthcare organizations located throughout the world in their efforts to obtain product certifications approvals
Prepare standards test reports and other documentation in accordance with applicable regulations.
Some travel will be required
Do you want to learn more about our business? Go to http://www.baxter.com/inside-baxter/about/overview/corporate.page ?
Who you are
BS or MS in Systems, Electrical or a related engineering field with 10 or more years experience in the design and implementation of complex systems. 5 or more years of experience in compliance engineering or regulatory affairs on small to medium scale projects utilizing formal standards testing methodologies.
Knowledge of medical device requirements for European Union, Canadian, Australian, and UL standards.
Ability to collaboratively influence product design, and troubleshoot compliance issues.
Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
Strong team player, able to meet deadlines and handle changing priorities
Good hardware interfacing background and extensive system integration experience with microprocessor hardware and software.
Experience in resolving complex technical problems using strong analytical skills
Excellent written, oral and interpersonal skills
Must be proficient at time management and multitasking
Knowledge of EMC phenomenon in Medical Equipment Strong electronics background is essential Knowledge of FDA's guidance on design controls and software validation, as well as ANSI/IEEE standards for engineering
Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
What we offer It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from! We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you. If you want to learn more about career opportunities go to http://www.baxter.com/careers.page
- Who we are * Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products. Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world. Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care. Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.
Every day at Baxter is a chance to save and sustain people's lives.
Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Job: *Research and Development
Organization: *R&D and Innovation
Title: Sr Principal Compliance Engineer
Requisition ID: 1700046D