Senior Mechanical Engineer - R&D
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
Participate in all aspects of the mechanical design of new electromechanical medical devices, accessories and consumables. Provide project leadership, specifications creation, perform engineering modeling and analyses, develop test methods and fixtures, document and communicate the design internally and to suppliers. Significant creativity and experience is essential, using engineering practices in the design, analysis and verification of components (injection molded, machined and sheet metal), assemblies, mechanisms and systems.
Primary Duties and Responsibilities:
Technical Development and Analysis (50%)
- Designs, develops, prototypes, measures, modifies and tests cost-effective mechanical 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, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer.
- Develop tests for design verification and validation for electromechanical and consumable 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 (40%)
- Rigorous documentation for all phases of product development, including design specifications, verification test plans, CAD models, drawings, and change orders associated with medical devices and accessories.
- Develop & maintain project plans, coordinate project activities, set/adhere to milestones, manage concurrent projects
- 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 personnel as needed for completion of specific tasks.
Quality, Compliance, and Regulated Practices (10%)
- Support compliance to Regulatory Requirements including electromagnetic interference/electromagnetic compatibility (EMI/EMC), 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, 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):
- BS Mechanical Engineering
- Working knowledge of finite element analysis, tolerance analysis, and geometric tolerances.
- 5 years experience as a design engineer developing electromechanical equipment and/or disposable medical products in a regulated industry
- Strong interpersonal and communication skills
- Ability to document prospective engineering analysis
- Strong problem solving skills
- Strong technical writing skills
- Design of injection molded, sheet metal and machined components
- Proficient in Solid Works, including drawing creation
- Working knowledge of statistics
- Experience in a regulated medical device industry
- Experience in disposables/plastics
- project management experience
- 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 actuators and/or pump design including screw drives, peri pumps, and motor controls/sizing, various valve types (check, pinch, piston, shear, etc)