Product Development Engineer

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

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.

The Product Development Engineer is responsible for managing all aspects of design and development for medical devices at BioHorizons in conformance with corporate procedures and FDA Quality System Regulations. These duties include developing medical device designs and prototypes, detailed specifications and design for manufacturability, design verification and validation activity. The Product Development Engineer shall possess knowledge of anatomy/physiology, biomaterials, and engineering principles to be applied to their essential duties and responsibilities.

Essential Duties and 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
• 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

Qualifications:

• Proficient in MSWindows and MSOffice applications (e.g. Word, Excel, PowerPoint)
• Proficient in CAD design software (e.g. SolidWorks) preferred
• Ability to interact with colleagues and customers in a professional manner
• Must possess good written and verbal communication skills
• Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design controls of medical devices preferred

Education/Experience:

• Bachelor of Science degree in an applicable Engineering discipline and/or combination of education and experience.
• Minimum of 3 years of medical device product design and development experience preferred
• 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
• 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
• Casual Dress Code
• Social events for employees and family

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.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.