Senior Mechanical Engineer - Medical Device Industry

Techtrueup•Minneapolis, MN

About The Position

We are seeking a Senior Mechanical Engineer to support the transfer and sustaining engineering of multiple product lines relocating from Boston to Minneapolis. These product lines include electroporation systems, precision syringe pumps, and ventilators. This role will lead and support manufacturing transfer activities, process development, documentation, and sustaining engineering, ensuring the successful ramp-up of production in Minneapolis while maintaining product quality, reliability, and regulatory compliance.

Requirements

Bachelor’s degree in Mechanical Engineering or a related discipline required.
Minimum of 6 years of mechanical engineering experience, preferably in life sciences or precision instrumentation.
Experience with design for manufacturability (DFM) and design for assembly (DFA).
Excellent problem-solving skills and ability to manage multiple projects simultaneously.
Ability to quickly understand, condense, organize and communicate information across disciplines to facilitate informed technical decision-making.
Strong knowledge of materials, fabrication and machining processes, cables and harnesses, assembly, testing and manufacturing processes.
Must be self-motivated and a team player, with personal responsibility to deliver on commitments.
Experience supporting complex electromechanical assemblies.
Analytical skills, technical aptitude, creativity and determination to implement effective solutions to difficult problems and analyze and coordinate data
Proficiency in 3D solid modeling, preferably SolidWorks

Nice To Haves

Experience with manufacturing transfers or new product introduction (NPI) preferred.
Experience with Agile, JDE, and Dozuki is a plus.

Responsibilities

Perform gap analyses of manufacturing processes, assembly procedures, engineering drawings, design history files, manufacturing test methods and process/design validation and verification methods.
Identify critical equipment and fixtures and manage the transfer/replication of equipment in Minneapolis.
Become a subject matter expert on manufacturing processes in preparation for a sustaining engineering role.
Coordinate the physical transfer of manufacturing equipment to Minneapolis.
Write process qualification plans and execute IQ/OQ/PQ activities.
Work with internal production teams to provide training and support to ensure a smooth product ramp-up.
Provide day-to-day manufacturing engineering support for production lines.
Troubleshoot manufacturing issues and drive root cause analysis and corrective actions.
Support engineering change orders (ECOs) and product improvements.
Identify, validate and implement design improvements or product line extensions.
Partner with Quality to investigate nonconformances, CAPAs, and field issues.
Ensure product line continuity by actively resolving component obsolescence and manufacturing infrastructure issues.
Maintain manufacturing procedures and design documentation.
Partner with Supply Chain to qualify and onboard suppliers.
Support quality audits and regulatory inspections.
Provide training to production technicians and operators.