Principal Engineer
Round Lake, IL
Req ID 51546BR
Business Title
Principal Engineer
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Some of the activities will include:
•Provide consultation and expertise to design engineers to resolve EMC issues
•Will work under the direction of the Compliance Engineering Manager to insure compliance of Baxter Healthcare hardware solutions with product performance standards requirements. Will also support efforts to comply with environmental regulations as needed.
•Interact with Product Management, Engineering and Customer Service organizations to insure that Baxter Healthcare service solutions comply with Product Performance Standards requirements in the markets for which they are targeted, both domestic and international.
•Keep abreast of changes to Product Performance Standards regulations affecting medical products.
•Occasional travel may be required to attend conferences and seminars.
•Supervise the operation of EMC test facility including an RF screen room.
•Insure that all Product Performance Standards test equipment complies with international requirements.
•Schedule Product Performance Standards testing of Baxter Healthcare products at onsite test facility and at commercial test laboratory when needed
•Insure compliance test equipment is well maintained and calibrated in accordance with international requirements.
•Submit documentation to regulatory authorities as required to obtain Product Performance certifications (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand)
•Develop GEHC strategy on standards that are applicable to products and processes that enable market access of medical devices in countries where GEHC conducts business
•Analyze & communicate proposed, new or changing requirements for standards, & lead teams to develop strategies, programs and processes to meet business objectives and ensure timely compliance with regulatory requirements.
• Develop strategy on standards that are applicable to products and processes that enable market access of medical devices in countries where Baxter conducts business
Responsibilities and Duties
•Supervise as well perform EMC testing on Radio Sensitive Devices products at on-site test facility and schedule 10 m emissions testing at local commercial test facility
•Keep abreast of changes to regulations impacting Radio Sensitive Device products through reading trade periodicals, attending conferences, searching the internet and networking within the standards community.
•Prepare product qualification submittal documentation to regulatory agencies
•Insure 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.
Job Requirements
BS or MS in electrical engineering with 10 or more years experience in the design and implementation of complex embedded software systems.
5 or more years of experience in compliance engineering on small to medium scale projects utilizing formal standards testing methodologies.
Knowledge of medical device requirements for European Union, Canadian, Australian, and UL standards
Knowledge of EMC phenomenon in Medical Equipment
Excellent understanding of EMC test equipment and testing method in accordance with domestic and international standards
Knowledge of EMC regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).
Ability to perform diagnostics and correct EMC failures in conjunction with design engineers
Strong electronics background is essential
Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
Experience with EMC design tools, automated EMC testing tools, electronic test equipment (scopes, logic analyzers)
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 FDA's guidance on design controls and software validation, as well as ANSI/IEEE standards for EMC engineering
Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
