BioHorizons Implant Systems Jobs Hiring Now

This position is onsite based in Hoover, AL and is not open to remote work.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.

An Associate Product Engineer supports the maintenance and improvement of existing company products and associated records. Performance in execution of these activities contributes to supplier, customer and regulatory agency perceptions of the company. An Associate Product Engineer assists with design changes, preparation and maintenance of design records, engineering documentation updates, and technical support of manufacturing activities under the guidance of more senior engineering personnel. The position coordinates closely with Manufacturing, Quality, Operations and cross-functional teams to support timely delivery of conforming products that meets or exceeds customer requirements.

Essential Duties and Responsibilities:

• Adhere with the company’s Quality Management System to ensure compliance with applicable regulatory requirements.
• Support the maintenance and improvement of existing products. This requires developing knowledge of:
  • Design of medical device parts and products.
  • General design requirements for:
    • Product function.
    • Interface with other products.
    • Ease of manufacture.
    • Aesthetics.
  • Drawing production per ASME Y14.5 including Geometric Dimensioning and Tolerancing.
  • Material composition requirements.
  • Surface finish requirements.
  • Existing company products.
• Assist in the proper creation of Design Records such as:
  • Document Change Request system:
    • Organize, track, and process Document Change Requests as assigned.
    • Distribute new and revised drawings for approvals and update master drawing files.
    • Support documentation of impact to existing product inventory (parts disposition).
  • Document Drawing Files:
    • Support superseding old drawings with new releases.
    • Assist with obsolescence of discontinued product drawings and other design records.
    • Update master drawing file index to reflect latest drawing revision.
• Support process and procedure development for manufacture and packaging of existing and new products such as:
  • Assist in addressing product manufacturing nonconformances.
  • Support real-time manufacturing solutions.
  • Assist with validation of processing and packaging activities as assigned.
  • Support product and process optimization efforts.
• Assist in the assessment of customer complaints requiring engineering assistance.
  • Support review of product trend investigation reports.
• Support planning and execution of testing and documentation activities associated with product changes.
• Maintain accurate technical documentation and communicate project status clearly to team members and management.

Qualifications:

• Must have good written and verbal communication skills.
• Must have strong attention to detail and ability to work effectively in a team environment.
• Must have the ability to manage multiple assignments while developing technical knowledge in a regulated environment.
• The ability to travel overnight may be necessary using standard modes of travel, the ability to rent a car and hotel.

Education:

• Bachelor of Science in Engineering (Mechanical Engineering, Biomedical Engineering, preferred) and/or equivalent work experience required.
• 0-3 years experience with standard MS Windows applications (Word, Excel) and CAD software package; 3-D modeling preferred.
• 0-3 years work experience in engineering, medical device field preferred; internship, co-op, or product support experience preferred.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.