Associate Principal Mechanical Engineer

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.