Job Title

Product Development Engineer

Location

Columbia, MD

Type

Full Time

Required Education

Minimum of a Bachelors degree in an Engineering discipline or possess the equivalent combination of education and experience.

Job Summary

Assist Product Development personnel with all aspects of Research and Product Development.

Experience

• Minimum of 3 years of Medical Device industry experience in a product development engineering position preferred.


• Experience with tissue based technologies or experience developing or refining biological implantable materials desirable.


• Experience in extracellular matrix processing with an understanding of the biological performance of collagen-based membranes in soft tissue. Xenografts, allografts, natural matricies; regenerative tissue (processing of materials). Natural, not synthetic desired.


• Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products.


• Experienced contributor to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives.


• Experience in generating test plans, writing protocols, and conducting design verification/validation and process validation testing.


• Working knowledge of the US and International standards governing the design, development, testing, and manufacture of medical devices.


• Experience / familiarity with U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices.


• Excellent written and verbal communication skills.

Job Responsibilities

• Perform research and development activities utilizing knowledge of anatomy/physiology, biomaterials, and basic engineering principles.


• Develop design testing methods, procedures and conducts prototype and design verification testing as directed. Provide written documentation and reports for testing.


• Participate in in-vitro and in-vivo studies including animal and human evaluations as part of product development.


• Update estimates, schedules, budgets, reports, and design control documents based on revisions and changes to the product designs and research projects.


• Investigate design changes and failures, product complaints and non-conformances. Report findings and recommendations in Company systems for corrective and preventive action.


• Assist in preparing and maintaining the departmental policies, procedures, and manuals.


• Submit new ideas for patent filing.


• Prepare Failure Mode Effects Criticality Analysis (FMECA) and risk assessments for product and processes.


• Assist in process/product validations of new and modified designs and processes.


• Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the company’s products.


• Generate test plans and reports in support of regulatory submissions.


• Interface with manufacturing, quality, regulatory, research and development, sales and marketing, outside vendors, and others to accomplish assigned tasks.


• Willingness & ability to travel (both domestic & international).


• Perform other duties as assigned.