Service Development Engineer

This Jobot Job is hosted by: Emily OlingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $85,000 - $120,000 per year

• Full Medical, Vision, and Dental (PPO and HMO)
• Bonus
• 401k matching
• FSA, Pet Insurance, Life Insurance, AD&D Insurance
• PTO and all major holidays
• 529 College Savings Plan
• Discounts at partnered retailers (gym, phones, etc.)

• Create, develop, implement, and execute specific FRU training procedures, and Field Replacement Instructions (FRI) to the Service organization. As well as provide sound technical support to staff such as: Service Support, and Field Service Engineers.
• Create BOM's, service work instructions, service bulletins, forms and/or service sign off sheets related to FRU instructions for Service personnel to perform appropriate installation, testing and documentation.
• Ensure that all instructions, procedures, and bulletins for capital equipment products are reviewed and properly released with appropriate instructions, cautions, and warnings for use by the customer and service personnel.
• Conduct projects in support of the Service organization for assigned products to develop and implement Service strategies and requirements; provide product servicing requirement analysis for design input; and assure the design for Service meets appropriate requirements for servicing and reparability.
• Complete all necessary activities as it relates to the Change Order process for new product FRUs during pilot production phase product launch and legacy products. This includes but is not limited to creating and driving service bulletin and product FRU releases, escalating and resolving design, manufacturing, and technical support issues.
• Interface at all levels of the organization such as engineering, planning, logistics, quality, marketing, and manufacturing functions as needed to accomplish required tasks.
• Manage escalation and resolution of extremely complex and unique field issues. Conduct investigations of product related customer issues and/or create service programs, as necessary. Resolve both internal and/or external customer complaints. If required or requested.
• Support the Sales Operations function with other tasks as designated and assigned if required.
• Provide support for product changes throughout the product life cycle.
• Work with cross functional disciplines to support the development of:

• Support the Quality System requirements by building quality into all aspects of work.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Clearly define what FRU kits and FRIs for Field Service Engineers and trained hospital repair personnel (Biomeds) will need to follow for field repairs.
• Understand, follow, and support our internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

• Thorough knowledge of manufacturing and servicing processes in the medical device space
• Ability to work independently or as a team with Service internally or Field Service Engineers, externally.
• Experience with repairing, refurbishing, and testing equipment.
• Familiar with a 3D solid modeling package, preferably Solid Works software. Adept use of MS Office suite.
• Ability to travel about 20% within the U.S. and internationally as necessary and required.
• Ability to use computer applications related to work, including Word, Excel, Outlook and PLM software (i.e. SAP).
• Knowledge of Engineering Change Order process, including the ability to create, prepare and release documentation through Documentation control procedures using PLM.
• Background in electromechanical in medical device area