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Drägerwerk AG & Co. KGaA • North Andover, MA

1d • Hybrid

About The Position

We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger, where we are guided by the principle “Technology for Life”. This role is based out of our beautiful Andover, MA facility, which offers many benefits, including an onsite fitness center with yoga and fitness training classes, onsite game rooms, a full-service café, free parking and more. Andover supports the design and assembly of our patient monitoring products. This is a hybrid position, requiring a minimum of 3 days a week in the Andover MA office. Travel up to 10%. Purpose : Ensure that products meet safety standards for 510(k) clearance and provide cost effective EMC design guidance needed for compliance with EMC and Safety requirements as they pertain to Medical equipment. Support NRTL and EMC test laboratories during the product approval process including support for FDA submissions. Be an active member of AAMI committees on Electrical Safety and Electromagnetics to influence Draeger’s position in standards development.

Requirements

• BS Electrical Engineering or equivalent experience.
• Minimum of 8 years previous in electrical design, analysis and trouble shooting in an engineering environment; medical device industry experience a plus.
• EMI / EMC subject matter expert.
• Ability to function as a team member as well as independently
• Ability to mentor others and coordinate and delegate activities of others
• Ability to apply technical knowledge to departments improvements and planning
• Ability to maintain complex detailed records and reports

Responsibilities

• Participate in design reviews to ensure safety requirements are integrated from the concept phase and provide detailed design guidance on PCB layouts, stack-ups, I/O EMC protection, isolation barriers, critical components, and leakage currents.
• Interpret and apply safety standards, primarily IEC 60601-1 (General safety).
• Plan, execute, or manage third-party lab testing for electrical safety, mechanical integrity, and thermal hazards.
• Provide technical safety data and performance testing results to support 510(k) efforts.
• Perform EMI testing and troubleshoot EMI problems as needed and recommend cost effective solutions with minimal design impact.
• Perform product safety testing for leakage currents and defibrillation.
• Prepare EMC and product Safety test plans and reports. This includes internal verification reports and documentation required by external testing agencies. Support product testing at EMC test houses and NRTL’s
• Duties related to the Andover standards management committee. Participate in AAMI committees on Electrical Safety and Electromagnetics to influence Draeger’s position in standards development.
• Work closely with Draeger Systems Engineering, Risk Management and Clinical Engineering groups developing product certification requirements.
• Support the customer complaint department by leading root cause analysis for safety-related non-conformances and any issues relating to EMC. Make on site visits when necessary.
• Performs other duties as needed and assigned.

Benefits

• Medical, dental, and vision insurance
• Life, short- and long-term disability coverage
• 401(k) with company match
• Over 4 weeks of paid time off, plus holidays and parental leave
• Flexible spending accounts and employee assistance program
• Select locations also offer free parking, an on-site gym, cafeteria, and game room.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees