Manufacturing Engineer III

Description:

ONSITE - 5 days per week/MG

Location: 1 Scimed Place, Maple Grove, MN

About the role:

We value collaboration and synergy. We are looking for a motivated, collaborative, and creative individual to join our high-performing Process Development team. This role will be focused on next generation technologies and products for the WATCHMAN device and will have strong opportunity for future growth. You will have the opportunity to drive innovative technology solutions from concept to commercialization. You will be partnering cross-functionally with a technically strong, experienced, and highly engaged team.

Responsibilities include:

• Owning equipment, processes, inspections, development builds, and driving improvements in the associated technology and methodology.
• Positioning future projects for success to continue driving Human Visual Inspection (HVI) reduction for Watchman manufacturing.
• Owning processes and key deliverables through DV, PV, and commercial launch.
• Working cross-functionally and collaborating heavily with R&D, Equipment Engineering, Manufacturing Engineering, and Design Assurance to develop product concepts, equipment, inspections, influence design specifications, and provide Design for Manufacturability (DFM) input to the engineering print package.
• Developing new assembly and inspection capabilities for complex equipment.
• Training, mentoring, and/or providing work direction to engineers and technicians and may train manufacturing personnel when required as part of a validation.
• Communicating technical data and recommendations in a clear and concise manner.
• Solving complex technical problems in a hands-on manner, and working in a fast-paced, dynamic environment.
• Developing, writing, & reviewing process validation strategy and related deliverables to meet quality system requirements. (e.g., Experiment tech reports, GR&R, TMV, IQ, FMEA’s, etc.)
• May serve as a core team member, workstream lead, or extended team member on new product development projects.
  
  

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  
  

Required qualifications:

• Bachelor’s degree in engineering or relevant technical field.
• Minimum of 4 years of professional experience relevant to this role.
• Prior experience in medical device or other regulated industry.
• Demonstrated cross-functional collaboration and influence in a technical environment.
• Experience with Automated Inspection and/or Assembly Equipment.
• Demonstrated understanding of problem-solving and root cause investigations.
• Expertise in New Product Development and/or Operations.
• Experience with Process Verification and Validation such as TMVs and OQ/PQs.
• Demonstrated understanding and usage of statistics to drive improvements.
• Strong written and verbal communication, decision-making, and critical thinking skills.
• Potential travel up to 10% of time. Travel will be local only - no overnight travel.
  
  

Preferred:

• Experience with Nitinol manufacturing.