Senior Product Development Engineer

Columbia, MD

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Job Description

Title: Senior Product Development Engineer
Department: Research & Development

Exempt or Non-Exempt: Exempt

Location: Columbia, MD

 

Position Summary

The Senior Product Development Engineer is responsible for managing all aspects of design development and testing for medical devices at ACell in compliance with the FDA Quality System Requirement. These duties include developing medical device designs and prototypes, detailed specifications and tolerances, and test methods. The Senior Product Development Engineer will develop the Design History File to support subsequent Regulatory submissions. The Senior Product Development Engineer will also assist in the development of strategic plans for particular product families, and will assist in training junior Product Development Engineers.

 

Essential Functions

  • Act as core team lead or support for design control activities
  • Perform research and development activities using knowledge of anatomy/physiology, biomaterials, and basic engineering principles
  • Develop design testing methods and procedures; conduct prototype and design verification 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
  • Assist in process/product validations of new and modified designs and processes
  • Mentor and manage junior Product Development Engineers
  • Update estimates, budgets, schedules, 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 for corrective and preventive action
  • Prepare Failure Mode Effects Analysis (FMEA) and risk assessments for products
  • 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 & Development, Sales, Marketing, and outside vendors to accomplish assigned tasks

Additional Responsibilities

  • Assist in preparing and maintaining the departmental policies, procedures, and manuals
  • Submit new ideas for patent filing
  • Perform other duties as assigned

Required Education and Experience

  • Minimum of a Bachelor’s degree in an Engineering discipline, or possess the equivalent combination of education and experience
  • Minimum of 5 years of medical device industry experience, preferably in a product development engineering position

Required Knowledge, Skills, and Abilities

  • Experience with tissue-based technologies or experience developing or refining biological implantable materials
  • Experience in Biocompatibility testing (ISO-10993) and Sterilization validation is a plus
  • Experience in extracellular matrix processing with an understanding of the biological performance of collagen-based membranes in soft tissue, including but not limited to xenografts, allografts, natural matrices, and regenerative tissue (processing of materials)—natural, not synthetic desired
  • Experience in mentoring and managing technical personnel
  • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products
  • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives
  • Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing
  • Working knowledge of the U.S. 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

Travel Requirement

·         Travel as needed (domestic and international). Travel time may be necessary based on business needs that can be as high as 20%.

 

Physical Requirements

  • Must be able to stand and/or sit for extended periods of time
  • Must be able to push, pull, squat, bend, and reach above shoulders
  • Repetitive use of hands
  • Ability to view computer screen for extended periods

 

Environmental Conditions

·         Combination lab/office setting; light to moderate noise, Personal Protective Equipment (PPE) provided if required

·         Open office work area, light to moderate noise

·         May require occasional wearing of sterile gowning attire when entering certain parts of facility

 

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All qualified applicants will receive consideration for employment, transfer or promotion without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability or veteran status.                            

 

 

 

 

 

 

 

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Skills & Requirements