Senior Mechanical Engineer
The Senior Mechanical Engineer will participate, and at times provide leadership, in the mechanical design of new and modified electromechanical medical devices as well as their sterile disposable counterparts. Responsibilities of this position include project leadership and execution for all aspects of design and modification including: requirements and specification creation, perform engineering modeling and analyses, develop test methods and fixtures, document and communicate the design internally and externally to suppliers. Significant creativity and experience is essential for this role, using engineering practices in the design, analysis, and verification of components (machined, sheet metal, injection molded, extruded, etc.), assemblies, mechanisms and systems. The Senior Mechanical Engineer must be a self-starter capable of driving challenging projects through a product development process both individually and in coordination with a team.
Technical Development and Analysis
Designs, develops, prototypes, measures, modifies and tests capital medical equipment as well as sterile disposables as part of electromechanical equipment development
Specification and qualification of new mechanical designs
Designs with knowledge of materials and manufacturing processes and understands the interdependencies/design constraints with other project team members
Exhibits cooperation and sound judgment in design tradeoffs resulting in reliable designs.
Design For: Quality, Reliability, Use, Sterilization, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer
Develop tests for design verification and validation for electromechanical products
Perform design verification activities
Simulation of systems as appropriate to assure product performance
Diagnose the causes of system failures and specify solutions
Develops intellectual property to maintain competitive advantage
Project Management and Documentation
Rigorous documentation for all phases of product development, including system requirements, design specifications, verification test plans, CAD models, drawings, and change orders associated with medical devices and accessories
Develop & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects
Develop & maintain verification and validation plans for successful submission to FDA and other regulating bodies
Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion
Interface with Operations teams to ensure smooth transfer of products into production
Direct outside contract manufacturer personnel as needed for completion of specific tasks
Quality, Compliance, and Regulated Practices
Support compliance to Regulatory Requirements including Underwriters Laboratories (UL), REACH/RoHS, and other environmental standards
Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
Ensures product meets requirements regulated by FDA, MDD, MDR, UL, IEC, CE and other governing bodies
Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications
Qualifications (Knowledge, Skills & Abilities):
Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by ACIST Medical Systems.
BS Mechanical / Manufacturing / Biomedical Engineering
5+ years of experience developing electromechanical devices in the medical device space or similar regulated industry.
Working knowledge of finite element analysis, tolerance analysis, and geometric tolerances.
Strong interpersonal and communication skills
Design of injection molded, extruded, machined, formed, sheet metal and other metal/plastic components
Proficient in SolidWorks, including drawing creation
Working knowledge of statistics
Ability to document prospective engineering analysis
Strong problem solving and technical writing skills
Advanced degree a plus
Drawing management system knowledge
Working knowledge of medical terminology
Knowledge of common sterilization processes (gamma, E-beam, EtO, etc)
Knowledge of common bonding and manufacturing processes such as solvents, UV adhesive, RF welding, etc.
Knowledge of QSR, ISO/EN and Quality System Standards
Project management experience
Familiar with use of 3D printing and design
Familiar with cath lab procedures used in diagnostic and interventional cardiac imaging as well as peripheral imaging, TAVR procedures, neuro imaging, and CT/MR imaging.
7905 Fuller Road Eden Prairie, Minnesota