Product Development Engineer I

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Full Time Maumee, OH, US

7 days ago Requisition ID: 1009

Summary of Position

The Product Development Engineer I position is an entry-level engineering role focused on supporting the development of new products and the redesign of existing products. Working under the guidance of senior engineering staff and management, the Engineer I is responsible for executing assigned product development activities in compliance with established product development processes, quality system requirements, and applicable regulatory standards.

Primary responsibilities include CAD design, prototype development, testing support, documentation generation, and coordination of development activities with internal teams and external vendors. The Engineer I is expected to develop technical knowledge, strengthen problem-solving skills, and build an understanding of medical device development processes throughout the product lifecycle.

Essential Duties and Responsibilities

New Product Development

• Serve as primary document controller for product development projects, assisting Product Development Engineer II and Project Manager as needed.
• Assist in product concept brainstorming
• Complete assigned portions of initial product assessments
• Create CAD models and engineering drawings
• Generate prototype iterations
• Coordinate prototype builds with vendors under guidance
• Support product testing and evaluation activities
• Assist with tooling reviews
• Support patent and regulatory submissions with documentation gathering
• Review marketing literature for technical accuracy
• Participate in tradeshow/product research activities
• Other Duties
• Support technology transfer evaluations

Assist with prototype coordination

Compile technical information for opportunity assessments

Support communications with universities/vendors

Quality

• Understand and follow quality procedures
• Support regulatory submissions
• Participate in CAPA/complaint investigations

• Quality

  • Understand and follow quality procedures
  • Support regulatory submissions
  • Generate documentation packages
  • Participate in CAPA/complaint investigations
  Executes engineering activities under direction of senior engineers or management.

Supervisory Responsibilities

• Oversee design, development and existing product maintenance efforts of department Interns and Co-Op Students.
• Maintain personnel files and performance reviews on department subordinates.
• Assist and supervise production personnel (as needed).

Authorities for Position

• Approve development related Device Master Record documentation as author
• Approve new, and red-lined, CAD geometries and drawings (Caveat: no person is authorized to unilaterally approve their own work).
• Approve product development/maintenance/testing related purchases up to the amount listed on the purchasing policy.

Competency Required for Position

• MS Office software suite proficiency
• Quality system awareness
• Basic regulatory requirement knowledge related to product development activities.
• Knowledge of various manufacturing processes and how they relate to our current & proposed product lines.

Qualifications Required for Position

• Bachelor’s Degree in mechanical engineering, other medically related engineering, or significant and relevant work experience.
• 0-3 years of medical product development experience with increasing level of responsibilities.
• Demonstrated ability to work as a member of a team to achieve goals.
• Demonstrated experience using a personal computer for word processing, design, and calculations.
• Ability to read and create mechanical drawings.
• Ability to read and write English at a 12th grade level.
• Ability to understand and act on complex verbal instructions.