OVERVIEW

As a leader in image guidance solutions, IMRIS Imaging, Inc. provides optimized, fully integrated image-guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Surgical Theatre enables intraoperative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils and OR tables for use in this unique and multifunctional intraoperative environment. It is estimated that over 70,000 patients have benefited from lifesaving or life-extending procedures performed in an IMRIS Surgical Theatre. IMRIS will continue to integrate new intraoperative imaging technologies and shape the future of neurosurgery in operating rooms worldwide.
We are searching for a Sr. Manufacturing Engineer to join our team. This role will be performed on-site and is based in the Greater Twin Cities area at our Chaska, MN headquarters. Please note: There is no relocation offered for this role. The ideal candidate should currently reside in the Greater Twin Cities area.
The Sr. Manufacturing Engineer will act as a liaison with internal and external customers in releasing new processes. The Sr. Manufacturing Engineer works with the Production Manager in the selection, development, and evaluation of production personnel to ensure efficient manufacturing operations. Additionally, the Sr. Manufacturing Engineer will provide high level technical expertise to integrated product team members for technical calculations, design and analysis functions, technical report writing, presentations and other engineering functions as required.
As a Sr. Manufacturing Engineer you will mentor less experienced members of staff and provide manufacturability oversight during the design phase thru new product introduction serving as the “eyes of the customer” before we introduce new technologies and designs to our customers.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS

• Bachelor or Master’s Degree in Engineering, or equivalent, or a combination of education and or experience
• 6+ years in a Manufacturing Engineering role preferably in medical device industry
• In depth understanding of strength of materials, electro/mechanical designs, plastic/metallic part assembly, product handling, part transfer and fixturing, process tooling, pneumatics, and machine control systems
• Process and product validation experience required
• Knowledge in Lean Principles and or Six Sigma or other problem solving methodology required
• Experience drafting CAD/3D modeling with emphasis in Solidworks, AutoCAD, VISIO
• Advanced in Microsoft Office Suite with emphasis in Work, Excel, and statistical data collection
• Strong organization and management skills
• Strong analytical skills
• A demonstrated ability to lead a focused production/technical problem solving team
• Expert in troubleshooting electromechanical systems
• Ability to read and interpret documents such as test procedures, manuals, engineering drawings and specifications is required
• Excellent interpersonal and communication skills, team player with the ability of working independently
• Experience with ERP/MPR system
• Systems engineering and interaction experience – hardware and software interface
• Ability to analyze and translate data to effectively report problems through written and/or graphical formats
• Ability to multi-task and set priorities without jeopardizing project schedule
• Able to define Bill of Material structure in support of defined build sequence and have the ability to create ECOs (Engineering Change Orders)
• Knowledge of Medical Device or similar quality and manufacturing systems would be very desirable
• Fixture design experience
• Ability to mentor less experienced members of staff
• Team focused but individually accountable
• Hands on and desire to be the Subject Matter Expert (SME)
• Front and backroom audit support
• While performing the duties of this job, the employee routinely is required to sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch
• The employee may occasionally lift and/or move up to 50 pounds
• The employee may be required to travel based on business needs
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Can work under deadlines
• May spend extended periods of time at a computer workstation
• Requires onsite presence to attend in-person work-related events, attend trainings and meetings to further ensure teamwork, collaboration and innovation
• A flexible workplace arrangement may be available to employees working in roles conducive to remote work (up to two days a week)

• Develop, implement, maintain, and improve current manufacturing processes, including equipment, documentation, training, gages and tooling/fixtures, to optimize quality, productivity and cost performance
• Participates in production teams, supply chain teams, Electrical/Mechanical/Systems design teams, and secures the agreed manufacturing requirements
• Provide production department with effective technical support to meet quality and quantity objectives
• Interface regularly with the Production Manager and Manufacturing Engineers to assure clear and concise communication in a leadership role
• Develop assembly and work instructions as well as documentation of processes including production travelers
• Responsible for maintaining medical device industry workmanship standard
• Performs risk assessment of processes and procedures
• Leads projects, working closely with Production, Maintenance, and Quality departments to implement the required changes to stabilize and improve processes
• Train employees in new or improved processes
• Leads the design for manufacturability process, prepares process FMEAs, root cause analyses, plans facility, equipment, and resource changes and initial product builds, and ensure that Manufacturing deliverables to Development Project Plans are completed and on time
• Conduct training on failure modes and effects analysis (FMEA) and facilitate meetings for engineering, production, and quality departments
• Engage with the appropriate personnel in the identification and resolution of corrective/preventative actions to address Safety, Quality, Technical, and Manufacturing issues
• Identify and implement corrective actions to resolve manufacturing product and process problems through testing, evaluation, and analysis
• Develop and implement continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness
• Lead safety initiatives
• Recommend and lead value added value engineering activities for manufacturability and cost reduction
• Implement a KANBAN system for manufacturing which reduce wasteful production activities and achieve labor reductions
• Recommend new standards and policies
• Evaluates prototype and manufacturing practices to develop optimized process flows to ensure repeatability and quality
• Write and validate assembly and test processes and procedures to be used in manufacturing
• Prepare and present reports summarizing information or trends related to manufacturing performance to cross-functional teams
• Serves as a mentor to less experienced team members on root cause analysis and problem solving methodologies and statistical analysis/process control
• Mentoring, motivating subordinates to reach peak performance; accountable for productivity improvement
• Assists in the identification, evaluation and implementation of new suppliers into the IMRIS system