Process Development Engineer II

Process Development Engineer II

Heraeus Medevio

Location Cartago

Permanent

Full Time

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.