SANUWAVE · 6 hours ago
Senior Manufacturing Engineer
Eden Prairie, MN
Full-time
Onsite
Senior Level
$60K/yr - $75K/yr
5+ years expSANUWAVE is a company focused on the development and optimization of manufacturing processes for regulated medical devices. The Senior Manufacturing Engineer will lead efforts in process validation, optimization, and compliance while collaborating with various departments to ensure effective and safe manufacturing practices.
Medical Device
Responsibilities
Execute the design, development, and optimization of manufacturing processes for new and existing medical devices
Participate in design changes, product updates, and sustaining engineering projects, ensuring continued compliance and performance
Support product transfer from R&D to manufacturing (NPI, scale-up, and commercialization)
Identify and implement process improvements to improve yield, quality, safety, and throughput
Guide supplier selection, qualification, and ongoing performance management
Apply SPC, capability studies, and data analysis to monitor and improve process performance
Plan, execute, and document process validation activities (IQ/OQ/PQ) in accordance with regulatory and quality system requirements
Execute standardization of manufacturing processes and workstations
Support CAPA, NCMR, deviation investigations, and risk assessments (FMEA, pFMEA)
Support capacity planning and equipment selection for growth
Execute characterization studies to understand critical process parameters and establish process limits
Serve as the primary technical liaison between internal engineering and contract manufacturers for process improvements, troubleshooting, and change management
Create and execute test protocols, analyze data, and write test reports for design verification
Ensure compliance with Lean Manufacturing, Six Sigma, or Operational Excellence initiatives
Translate product requirements and design specifications into robust manufacturing processes
Define and implement process controls to ensure consistent product quality and compliance
Perform failure mode and effects analysis for both design and manufacturing
Define verification methods (inspection, analysis, testing, or demonstration) to ensure traceability to design inputs
Calibrate, preventively maintain, and keep records of equipment and tools
Ensure the company’s manufacturing processes are compliant with all required regulations
Coordinate equipment maintenance, repairs, and calibrations to minimize downtime
Provide remote and on-site technical training or guidance to Contract Manufacturers and production personnel as needed
Create and execute test protocols, analyze data, and write test reports for design verification
Design or specify tooling, fixtures, and test equipment required for production processes
Perform other duties as assigned or required
Qualification
Required
Bachelor's degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline
5+ years of experience in the medical device industry
5+ years of experience in medical device product development, verification & validation, or process/manufacturing engineering
5+ years of experience with specific manufacturing processes, equipment, or industries, including but not limited to ultrasonic welding, transducer manufacturing, injection molding, circuit board manufacturing, medical device industry, tensile testers, leak flow testers, and calibration equipment
Proven experience with process validation (IQ/OQ/PQ) and statistical tools (SPC, DOE, GR&R)
Proficient with CAD and fixture design
Familiar with ultrasound technology
Experience working with contract manufacturers or global suppliers
Familiarity with risk management (PFMEA, DFMEA) and process controls
Able to function with urgency in high-pressure situations
Excellent verbal, written communication, especially with development and quality teams
Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment
Preferred
Familiarity with Injection Molding and Ultrasonic welding a plus
Lean Manufacturing and/or Six Sigma certification
Early stage/start up experience strongly preferred
Company
SANUWAVE
As an emerging leader in the development and commercialization of energy transfer technology, SANUWAVE presents products that help expedite wound healing on a cellular level.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Morgan Frank
CEO/Chairman Of The Board Of Directors
Pete Stegagno
Chief Operating Officer
Company data provided by crunchbase