BioHorizons · 13 hours ago
Product Development Engineer
Alabama, Hoover, AL, US
Full-time
Onsite
Mid Level
3+ years expBioHorizons is a company focused on medical devices, and they are seeking a Product Development Engineer responsible for managing design and development processes in compliance with FDA regulations. The role involves developing medical device designs, prototypes, and documentation while collaborating with various departments to ensure product feasibility and compliance.
Medical DeviceHealthcareDentalHealth CareLaser
No H1B
Responsibilities
Develop concept designs based on design inputs
Develop product specifications, support prototype development, create and execute testing methodologies, and maintain detailed documentation to evaluate design feasibility
Investigate and report on industry and non-industry technologies
Submit ideas for patent filings
Evaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate procedures
Support project scope development
Generate design inputs and outputs to support the development process
Develop Design History Files and support subsequent Regulatory submissions
Create design verification and validation test plans and reports
Execute design verification and validation testing
Generate risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new products
Design and implement new methodologies, materials, and/or processes to bring concepts to market
Participate in in-vitro and in-vivo studies, including animal and human evaluations as part of the development process
Interface and collaborate with Manufacturing, Quality, Regulatory, Quality, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasks
Present to colleagues and customers on products, device design, and applied engineering principles
Occasional travel may be necessary
Perform other duties as directed
Qualification
Required
Proficient in MSWindows and MSOffice applications (e.g. Word, Excel, PowerPoint)
Ability to interact with colleagues and customers in a professional manner
Must possess good written and verbal communication skills
Bachelor of Science degree in an applicable Engineering discipline and/or combination of education and experience
Preferred
Proficient in CAD design software (e.g. SolidWorks)
Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design controls of medical devices
Minimum of 3 years of medical device product design and development experience
Benefits
2 comprehensive medical plan options to choose from available the first of each month following your date of hire
Flexible Spending Account or HSA Account available
Vision Benefits
Company paid Dental Insurance for employee and dependents
Wellness Plan
401k with 5% matching
Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
Company paid Short Term Disability
Long Term Disability
Company provided Life Insurance
Paid Parental Leave
Casual Dress Code
Social events for employees and family
Company
BioHorizons
BioHorizons, Inc., a majority-owned subsidiary of Henry Schein, Inc.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$64.06MKey Investors
Deerfield,Piper Sandler
2012-12-19Series Unknown· $1.5M
2011-11-11Series Unknown· $12.56M
2011-06-30Debt Financing· $50M
Leadership Team
S
Steve Boggan
President and CEO
Todd Strong
COO
Recent News
GlobeNewswire News Room
2025-07-07
2023-12-25
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2023-12-25
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