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 inputsDevelop product specifications, support prototype development, create and execute testing methodologies, and maintain detailed documentation to evaluate design feasibilityInvestigate and report on industry and non-industry technologiesSubmit ideas for patent filingsEvaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate proceduresSupport project scope developmentGenerate design inputs and outputs to support the development processDevelop Design History Files and support subsequent Regulatory submissionsCreate design verification and validation test plans and reportsExecute design verification and validation testingGenerate risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new productsDesign and implement new methodologies, materials, and/or processes to bring concepts to marketParticipate in in-vitro and in-vivo studies, including animal and human evaluations as part of the development processInterface and collaborate with Manufacturing, Quality, Regulatory, Quality, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasksPresent to colleagues and customers on products, device design, and applied engineering principles  Occasional travel may be necessaryPerform other duties as directed

 

Qualifications:

Proficient in MSWindows and MSOffice applications (e.g. Word, Excel, PowerPoint)Proficient in CAD design software (e.g. SolidWorks) preferredAbility to interact with colleagues and customers in a professional mannerMust possess good written and verbal communication skillsExperience/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

 

Benefits:

 

2 comprehensive medical plan options to choose from available the first of each month following your date of hireFlexible Spending Account or HSA Account availableVision BenefitsCompany paid Dental Insurance for employee and dependentsWellness Plan401k with 5% matchingGenerous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service HoursCompany paid Short Term DisabilityLong Term DisabilityCompany provided Life InsurancePaid Parental LeaveCasual Dress CodeSocial 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.