R&D Engineer- Medical Device #9881

ECI; Arden Hills (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

ECI seeks an experienced R&D Engineer to lead design control activities for class II/III medical devices. You will remediate DHFs, drive risk management, and manage verification/validation across multidisciplinary teams to ensure regulatory compliance.

Bachelor’s in Biomedical/Mechanical/Electrical engineering with 5+ years in medical devices is required. Proficiency with Minitab and electronic document systems is preferred.

Qualifications

• Minimum of 5 years direct experience in medical device industry.
• Bachelor’s Degree in Biomedical/Mechanical/Electrical engineering or equivalent.
• Broad regulatory knowledge in medical devices (Class II and III).
• Vast experience in writing/reviewing design control documents and compilation of DHFs.
• Experience with Minitab Statistical software.
• Experience with electronic documentation management systems (Windchill, Agile PLM, IBM Doors).

Responsibilities

• Review Design History Files (DHF) for compliance gaps and document remediation plan.
• Lead DHF remediation projects with cross-functional teams.
• Develop and update design control documentation, risk management deliverables, and reports.
• Coordinate documentation with R&D, design QA, regulatory, clinical affairs, and marketing.
• Develop, execute and summarize DVMP, design verification and validation protocols and reports.
• Develop and validate test methods and analyze results.
• Support product specifications development and testing.

Skills

Attention to detail

Communication

Problem solving

Interpersonal skills

Regulatory knowledge

Minitab

Office 365

Design controls

DHF remediation

Documentation

Education

Bachelor’s Degree in Biomedical/ Mechanical/ Electrical Engineering

Tools

Windchill

Agile PLM

IBM Doors

Job description

About ECI
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.

Brief Description
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 R&D 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 project with design control related 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.

What You Will Do

• 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:
• Leads and successfully contributes 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, including engineering/technical protocols and reports
• Update/develop all associated documentation related to DHFs. This may include 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 comply 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.
  

What You Will Bring

• 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.
• Computer Skills: Advanced computer skills including Office 365 applications (Word/Excel/Visio/PowerPoint/Project/Teams, etc.).
• Experience with Minitab. Experience with electronic documentation management system (e.g,Windchill, Agile PLM, IBM Doors, etc.) is desired.
• Minimum of 5 years direct experience in medical device industry.
• Education: Bachelor’s Degree in Biomedical/ Mechanical/ electrical engineering or equivalent is required.
• Broad and in depth regulatory knowledge in medical device (Class II and III medical devices)
• Vast experience in writing/reviewing design control documents and compilation of DHFs
• Experience with Minitab Statistical software
  

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.