Senior Engineer - Product Development Engineering

JOB PURPOSE

Lead design and development activities throughout the lifecycle of products, design validation on complete medical device development programs.

MAJOR RESPONSIBILITIES

• Create technical execution plan and deliverables with the project manager to set realistic dates, accomplish milestones and meet customer’s needs.
• Lead and execute design and development project-related activities within the internal team to accomplish milestones and meet customer’s needs.
• Lead customer interaction on technical deliverables comfortably and confidently to tailor the product to customer’s needs.
• Lead activities for concept generation with strong technical problem-solving skills to tailor the product to customer’s needs.
• Mentor engineers on the team to conduct engineering analysis on designs, concepts, and the associated research to diminish execution risks.
• Lead and monitor documentation practices for requirements, design output, design verification, and testing using Heraeus and/or customer’s QMS to abide to the company’s quality systems.
• Communicate complex information concisely and clearly to all levels of collaborators, including customers, team members, and others to ensure assertive communication in all areas.
• Mentor technicians and less experienced engineers throughout project execution to diminish execution risks.
• Facilitate and make technical decisions on projects (i.e. vendor selection, critical to quality on the design, concept selection, etc.) to accomplish milestones and guarantee a successful project closure.
• Carry out supervisory responsibilities in accordance with the Company's policies and applicable laws to accomplish milestones and guarantee a successful project closure.
• Supervisory responsibilities include but not limited to the selection, training, and development, assigning work, and performance management of employees to have a trained and engaged team.
• Manage the time and attendance, expense review and approval, compliance assurance and purchasing authorization for direct reports via multiple online tools to guarantee a successful project closure.

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Bachelor’s degree in Engineering or related technical field required. Mechanical Engineer desirable.
• Master’s degree in Engineering or related technical field helpful (preferred).

Experience

• Minimum of 5+ years of relevant work experience in medical device industry.
• 8+ years of relevant work experience in engineering is nice to have.

License or certification required

• Solid Works.
• Six Sigma Green and/ or Black Belt

Knowledge and skills

• Well established knowledge of multiple engineering functional areas (i.e. product development, test, modeling, process, etc.).
• Knowledge of ISO 13485 Design Control and Process Validation documentation required.
• Knowledge of clinical applications for interventional medical procedures is preferred.
• Independently applies knowledge of the methodology for process/design selection.
• Able to communicate complex technical concepts to broad audiences.
• Highly effective communication and technical writing skills in Spanish and English
• Able to make data driven decisions utilizing statistical tools such as DOE, tolerance stack-up analysis, or Minitab.
• Knowledge of and effective application of engineering tools (e.g. CAD, FMEA, Process Validation).
• Strong independent problem-solving skills and active work to coach others in this area.
• Proficient with new technology development