Position Summary:
Perform all aspects of mechanical design from the initial feasibility stage to manufacturing release for use in medical diagnostic equipment. Using knowledge of electro-mechanical components, design for manufacturing, drawings, inspections, and CAD. Supports and optimizes instrument manufacturing activities. Provide SME support for existing product lines.
Responsibilities:
- Lead in the definition, proof of concept, development, implementation and/or support of mechanical designs to support department projects and objectives in the manufacture of medical devices.
- Troubleshoot and utilize problem-solving tools to resolve issues with process and/or product.
- Remain current on technological advancement in the relevant area of expertise.
- Ensure quality of deliverables by following the appropriate design practices and departmental procedures for design control and regulatory compliance.
- Create appropriate documentation such as technical communications, reports, meeting notes, change management, and other relevant technical documentation.
- Prioritize activities within the scope of the assignments to ensure schedules and quality of work is successfully achieved.
- Participate in material planning activities.
- Perform reviews related to risk analysis, change control, verification, validation, and other functions within the department.
- Define, review, and check product Bill of Materials (BOM), assembly instructions, and test procedures for implementation into Manufacturing.
- Work cross functionally with internal departments and lead project teams.
- Mentor less experienced team members to facilitate technical development and increase knowledge of business practices.
Studies and Experience:
Requires Bachelor’s Degree in Mechanical, Industrial or Manufacturing Engineering with 5+ years of engineering experience or Master’s Degree in Mechanical, Industrial or Manufacturing Engineering with 2+ years of engineering experience. Medical Device field is preferred.
Thirteen (13) years of relevant experience performing engineering functions will be accepted in lieu of Bachelor's Degree.
Knowledge of electro/mechanical production processes.
- Technical skills in the relevant Manufacturing Engineering disciplines.
- Ability to articulate complex technical concepts and resolutions.
- Knowledge and experience in Lean Manufacturing techniques and production processes.
- Experience managing large scale projects requiring multiple team members and launch schedules beyond 6 months.
- Basic understanding in programming techniques (e.g. C, C++, Python) and/or script writing (using LabVIEW, Arduino, PLCs, or similar).
- Experience with FDA, QSR, and ISO quality systems. (preferred).
Skills and Qualifications:
Required:
- Organization, timeliness, and quality of technical development activities.
- Quality and completeness of documentation.
- Development of personal autonomy and time management skills with the ability to handle multiple assignments and tasks.
- Knowledge of CAD (SolidWorks, Creo, NX), PLM (Windchill), and ERP systems (SAP).
- Knowledge of technical drawings (with GD&T).
- Knowledge of electro/mechanical production processes.
- Quality and completeness of documentation.
- Ability to articulate complex technical concepts to a non-technical audience.
- Ability to communicate with team members and other groups effectively.
- Proficiency in Microsoft Office applications (Word, Excel, Power Point, and Project).
Preferred:
- Working knowledge of Scripting (Visual C#, python, or other)
- Knowledgeable in manufacturing automation.
- Experienced in design for manufacturability, assembly, and serviceability.