Associate Principal Mechanical Engineer - Biofire

Support and sustain Instrument Manufacturing activities to facilitate efficient operations within the production environment, optimize existing processes and ensure established production goals are achieved.  Mentor and lead engineers and technicians to ensure the successful design, development, testing and implementation of both product and process changes in support of quality and cost reduction improvements.  Be responsible for the product throughout the product’s lifecycle. 

Primary Responsibilities: 

• Assists in the definition, proof of concept, development, implementation and/or support of technical or business solutions by performing specific tasks within the scope of the assigned activity.
• Identifies issues and uses problem-solving tools to formulate the necessary activities to provide successful solutions.
• Remains current on technological advancement in the relevant area of expertise to provide solutions that improve the product or process related activity.
• Ensures quality of deliverables by following the appropriate design practices and departmental procedures for design control and regulatory compliance.
• Creates appropriate documentation such as technical communications, reports, meeting notes and other relevant technical documentation within the role’s function.
• Prioritizes activities within the scope of the assignments to ensure schedules or quality of work is successfully achieved.
• Mentor team members to facilitate growth of technical or business expertise.
• Performs technical and process reviews related to risk analysis, change control, verification, validation, and other functions within the role.
• Ability to define, review and check product Bill of Materials (BOM) structures, assembly instructions and test procedures.
• Works with internal department and project specific teams.

Education, Skills & Experience:  

• Requires Bachelor’s Degree in Mechanical Engineering with 8+ years of engineering experience OR
  • Master’s Degree in Mechanical Engineering with 5+ year of engineering experience. Medical Device field is preferred.     
• 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
• Knowledge of FDA, QSR and ISO quality systems.
• Knowledge of CAD systems (Solidworks, CREO, Unigraphix)