DHF Senior Engineer #9201

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role

As a DHF Senior Engineer, you will lead and support design control related activities for the class II and III medical devices and combination products. The successful candidate will support design history file remediation projects with design control expertise as part of the project team. The position offers opportunities to work in multidisciplinary teams, across projects, where specific contribution within quality systems is a key element for success.

Responsibilities

• Review of Design History Files (DHF) and/or associated documentation for compliance gaps to regulations, standards and/or the company’s quality management system requirements.
• Document a comprehensive gap assessment report summarizing applicable regulatory and/or standards deficiencies.
• Develop a summary of recommendations for successful remediation of the DHF.
• Execute remediation of each DHF file based on the gaps identified:
  • Lead and successfully contribute to DHF remediation project teams typically including the following activities: design and development plan, design reviews, design input, design output, risk management, usability studies, design verification and validation, test method development and validation, research investigations, report preparation, and process/test documentation ensuring compliance to design control requirements.
  • Support product specifications development, engineering/technical reports to support product specifications.
  • Update/develop all associated documentation related to DHFs, including all elements of design control.
  • Coordinate documentation activities with other functional groups including research and development, design quality assurance, regulatory compliance, clinical affairs, and marketing.
• Develop risk management deliverables in compliance with ISO 14971.
• Develop usability documentation in compliance with ISO 62366.
• Develop, execute, and summarize System DVMP, design verification and validation protocols and reports.
• Develop and validate test methods.
• Compile, summarize, and analyze test results.
• Develop retrospective analysis to support the continued marketing of the devices.
• Ensure that all required technical documentation for medical devices complies with company and regulatory requirements.
• Support and participate in key project meetings, e.g., design reviews.
• Lead effectively within a technical and project team environment, including conducting meetings and presentations, planning and tracking projects, etc.
• Build Quality into all aspects of their work by maintaining compliance to all quality and regulatory requirements.

Requirements

• Minimum of 7 years direct experience in the medical device industry.
• Bachelor’s Degree in Biomedical, Mechanical, or Electrical Engineering or equivalent is required.
• Broad and in-depth regulatory knowledge in medical devices (Class II and III medical devices).
• Vast experience in writing/reviewing design control documents and compilation of DHFs.

Skills

• Accurate – Ability to perform work accurately and thoroughly.
• Communication (Written/Oral) – Ability to communicate effectively in written and oral form. Excellent report writing skills essential.
• Problem Solving – Ability to find a solution or deal proactively with work-related problems.
• Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers.
• Demonstrate strengths in identifying creative and efficient solutions to engineering challenges, translating customer requirements into workable product ideas and solutions. Good analytical and problem-solving skills.
• Advanced computer skills including Office 365 applications (Word/Excel/Visio/PowerPoint/Project/Teams, etc.).
• Experience with Minitab.
• Experience with electronic documentation management systems (e.g., Windchill, Agile PLM, IBM Doors, etc.) is desired.