Senior Human Factors Engineer

About the role

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Senior Human Factors Engineer, based in Boston, MA; OR Raynham, MA.

Responsibilities

• Lead human factors efforts for programs from concept through post market support, supporting and influencing usability activities for product lines and programs with minimal oversight
• Develop an understanding of intended use environments gained through time spent in the field, with a good understanding of intended user types formed through interactions with users
• Require work on problems of diverse scope that impact the broader program team and business, and contributes to projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations
• Network with key contacts outside own area of expertise, contributes information to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development

Requirements

• University/Bachelor's Degree in Human Factors Engineering (HFE), or Usability Engineering
• 4 to 6 years work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
• Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
• Medical Device product development or experience working in a highly regulated industry is a strong plus.
• Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus
• Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
• Knowledgeable in the IEC 62366 standard and the FDA guidance on human factors engineering
• Good knowledge of the ISO 14971 and IEC 62304 are a plus
• Fluent in English. German and French are an advantage
• Ability to travel up to 20%, domestic and international is required

Qualifications

• University/Bachelor's Degree in Human Factors Engineering (HFE), or Usability Engineering
• 4 to 6 years work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
• Demonstrated ability with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
• Medical Device product development or experience working in a highly regulated industry is a strong plus.
• Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus
• Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
• Knowledgeable in the IEC 62366 standard and the FDA guidance on human factors engineering
• Good knowledge of the ISO 14971 and IEC 62304 are a plus
• Fluent in English. German and French are an advantage
• Ability to travel up to 20%, domestic and international is required

Skills

• Analytical Reasoning
• Coaching
• Human Factor Engineering
• Manufacturing Engineering
• Product Design
• Product Improvements
• Prototyping
• Research and Development

Benefits

• Consolidated Retirement Plan (pension)
• Savings Plan (401(k))
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Pay

The anticipated base pay range for this position is : $92,000.00 - $148,350.00