Product Development Engineer
Biomedical Structures - Warwick, RI

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General Summary:

  • Leads implantable medical device new product development programs with a focus on project management, design control, and design/process validation deliverables.
  • Designs and develops medical textile based structures covering weaving, knitting, braiding, and non-woven textile applications and value added processes.
  • Demonstrates a high degree of intrapersonal skill with ability to fosters key customer relationships and participate on high performing teams.
  • Develops products based on customer needs and specifications.
  • Researches and implements new technologies/capabilities required to meet customer’s needs.

Principal Duties and Responsibilities:
Lead and function as a contributing member of multidisciplinary project teams in the design, development, and manufacturing of medical device components:

  • Develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports.
  • Prepare project management deliverables including timelines with milestones.
  • Create risk management and design control documents – per ISO 13485 including process flow charts, PFMEA, and control plans.
  • Support project teams on selecting materials, appropriate manufacturing techniques, and developing textile components and related value added capabilities for medical device design.
  • Interact with customers, medical device engineers to understand the unmet needs and offer solutions.
  • Interact with outside vendors, suppliers, and consultants.

Education and/or Experience:

  • BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.
  • Minimum of 3-6 years of experience with implantable medical device new product development in compliance with QSR and ISO 13485 requirements.
  • Must be capable of handling multiple projects/tasks at the same time.

Preferred Qualifications

  • Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus).
  • Experience working with bio-absorbable polymer based implantable medical devices.
  • Experience in the cardiovascular and/or orthopedic implantable medical device industry.
  • Direct experience with Knitting, Weaving, Braiding or Non-woven product development, fine denier constructions..

Other Skills and Abilities:

  • Good interpersonal relationship and people skills. Strong team player.
  • Potential to lead project team.
  • Ability to incorporate manufacturability into the new product development.
  • Excellent verbal and written communication skill.
  • Have passion and enthusiasm for innovation.
  • Proven problem solving skills.
  • Good understanding of statistical tools and DOE
  • Comfortable with all applications of MS Office