POSITION SUMMARY:

The Senior Mechanical Engineer will participate, and at times provide leadership, in the mechanical design of new and modified high volume disposable medical devices, accessories, and electromechanical medical devices. Responsibilities of this position include project leadership and execution for all aspects of design and modification to disposables development, 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. This individual will partner closely with and work through contract manufacturers to produce samples and production level goods. Significant creativity and experience is essential for this role, using engineering practices in the design, analysis and verification of components (injection molded, extruded, machined, sheet metal, etc), assemblies, mechanisms and systems. Candidate must be a self-starter capable of driving challenging projects individually and as a group through a PDP process.

PRIMARY DUTIES AND RESPONSIBILITIES:

Technical Development and Analysis:

• Designs, develops, prototypes, measures, modifies and tests cost-effective sterile disposable systems 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.
• Orchestrate sterilization validations, biocompatibility testing, particulate testing, etc to establish clean and sterile products.
• 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

Required Skills

MINIMUM:

• 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

• 8+ years experience in a Design Engineer role developing sterile disposable medical devices, preferably with involvement in 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

• Ability to document prospective engineering analysis

• Strong problem solving and technical writing skills

• Design of injection molded, extruded, machined, formed, sheet metal and other metal/plastic components

• 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.

• Proficient in SolidWorks, including drawing creation

• Working knowledge of statistics

PREFERRED:

• Advanced degree a plus
• Drawing management system knowledge
• Working knowledge of medical terminology
• 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.

Required Experience

MINIMUM:

• 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

• 8+ years experience in a Design Engineer role developing sterile disposable medical devices, preferably with involvement in 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

• Ability to document prospective engineering analysis

• Strong problem solving and technical writing skills

• Design of injection molded, extruded, machined, formed, sheet metal and other metal/plastic components

• 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.

• Proficient in SolidWorks, including drawing creation

• Working knowledge of statistics

PREFERRED:

• Advanced degree a plus
• Drawing management system knowledge
• Working knowledge of medical terminology
• 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.