The Manufacturing/Sustaining Engineer will focus on providing the highest level of engineering support for devices being developed and installed in the field and support ongoing sustaining engineering projects. Other daily responsibilities to include support of development team, contract manufactures along with providing support to R&D projects as requested.

Job Summary: Manufacturing /Sustaining Engineer

• Provide hands on technical support and guidance to customer service representatives as well as directly to customers.
• Provide hands on technical support to sustaining the current product.
• Provide hands on technical support to product development, including product design/enhancements, design for manufacturability with a focus on cost-effective, consistently produced, high quality products.
• Participate in the R&D plan supporting the development and launch of next generation technologies and related services.
• Collaborate on decisions regarding outsourcing, creating efficiencies and decreasing product costs for the Company while simultaneously protecting Galen’s intellectual property.
• Champion the Company’s culture with an emphasis on team building, empowerment, accountability, creativity, achievement and speed.
• Achieves objectives and project completion within budget and timeline.
• Provide technical hands-on support to drive engineering activities, including supporting product design/enhancements,
• Ensure implementation and refinement as required of formal process to support established engineering processes.
• Provide support to ensure all new products are designed for manufacturability.
• Effectively manage all aspects of the engineering effort including project teams and engineering services.
• Provide support and oversee outside vendors and consultants as required.
• Proactively support Company goals and objectives, policies and procedures, the Quality System Regulation, ISO/MDD regulations, and other regulatory requirements.
• Maintain a professional and credible image with key physicians, consultants, suppliers, and co -workers.
• Perform other duties as assigned.

Essential Functions:

• Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
• Support a work environment of continuous improvement that supports Galen’s Quality Policy, Quality System and the appropriate regulations for the area supported.
• Keep manager informed of changes in work schedule and/or workload.
• Regularly recommend and implement methods of improving the customer experience.
• Support Company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

Education Requirements:

• Bachelor’s Degree in engineering or equivalent experience is required.

Experience Requirements:

• Minimum 1-3 plus years related experience in the medical device industry in an engineering role or equivalent is required.

Skills/Qualifications/Competencies:

• Ability to think outside the box and come up with creative solutions to advance and support our solutions.
• Ability to manage diverse, simultaneous projects of varying complexities.
• Strong relationship, and problem-solving skills.
• Professional and positive approach, self-motivated, team player, creative with the ability to work on own initiative.
• Hands on mechanical and technical capability.
• Ability to work in front of the customer at the customer site.

Physical Factors:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must be able to lift 60lbs
• Position requires sitting for prolonged periods as well as stand for periods of time.

Working Conditions:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Unplanned Activities:

• Other duties as assigned