Medical Device Product Development Engineer (Onsite)

BioHorizons; Hoover (AL); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

401k with matching

Dental Insurance

Wellness Plan

Paid time off

Job summary

BioHorizons in Hoover, AL is seeking a Product Development Engineer to oversee design and development of medical devices in compliance with FDA QSR and corporate procedures.

You will develop concepts, create specifications, perform verification and validation, and prepare DHFs for regulatory submissions while collaborating across Manufacturing, Quality, Regulatory, and R&D teams. A BS in engineering and 3+ years in medical devices are required.

Qualifications

• Bachelor of Science degree in an engineering discipline.
• Minimum of 3 years of medical device product design and development experience.
• Experience with FDA, GMP, and ISO design controls preferred.
• Proficient in MS Windows and MS Office (Word, Excel, PowerPoint).
• CAD design software experience, SolidWorks preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Develop concept designs based on design inputs.
• Create design specifications and support prototype development, testing methodologies, and documentation.
• Develop design history files and support regulatory submissions.
• Generate design verification and validation test plans and reports.
• Interface with Manufacturing, Quality, Regulatory, R&D, Sales, and outside vendors to accomplish tasks.
• Occasional travel may be necessary.

Skills

Interpersonal skills

Professional communication

Regulatory knowledge

Education

Bachelor of Science in engineering

Tools

SolidWorks

Job description

BioHorizons in Hoover, AL is seeking a Product Development Engineer to oversee design and development of medical devices in compliance with FDA QSR and corporate procedures.

You will develop concepts, create specifications, perform verification and validation, and prepare DHFs for regulatory submissions while collaborating across Manufacturing, Quality, Regulatory, and R&D teams. A BS in engineering and 3+ years in medical devices are required.