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SUPERVISOR’S TITLE: Senior Manager, Product Development
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PURPOSE OF POSITION: The Staff Engineer, Human Factors will provide device development and human factors engineering support to drug delivery platforms over the product lifecycle. This job contributes to the organization by providing research and design input to translate user needs into functional product requirements and features. The position also organizes and oversees human factors, and associated risk management, activities and documentation to meet development agreement requirements with drug partners. This individual will work closely with other engineers, designers, manufacturing, marketing, and regulatory staff to assure user needs are met.
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QUALIFICATIONS:
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Required:
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- BS, MS or PhD in Human Factors / Usability Engineering, Biomedical Engineering or related field from an accredited university.
- At least 8 years applying human factors principles; OR a master’s degree plus 6 years’ experience.
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Preferred:
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- Experience in combination product development engineering in a pharmaceutical, medical device, regulated environment or related field.
- Experience representing human factors body of work to regulatory agencies and during audits.
- Experience working in matrix managed teams and participating on more than one project at a time.
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Skills & Competencies:
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- Experience applying Human Factors / Usability Engineering, including design and execution of formative and summative studies, to the design and development of medical devices or consumer products is required.
- Working knowledge and experience with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards is required.
- Effective communicator in team environments with strong interpersonal skills and can interface effectively with research, operations, and external suppliers and manufacturers.
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.
Physical Requirements:
- Must be able to remain in a stationary position for extended periods of time
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
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RESPONSIBILITIES:
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- Contribute to human factors efforts for a range of platform programs for drug delivery devices.
- Provide leadership in Human Factors / Usability Engineering in the design, development, testing, and commercialization of pharmaceutical delivery systems [medical devices] working closely with stakeholders in Regulatory, Quality, Manufacturing, Clinical and Commercial.
- This individual will be working with early and late stage development programs as well as life-cycle management projects to evaluate device usability, perform usability risk analyses, design and conduct formative human factors studies, recommend and develop design improvements to address usability issues.
- When appropriate, identify and partner with external human factors experts to develop protocols for and conduct formative and summative studies.
- Write HF-related documentation such as HF summary reports, contribute HF sections to regulatory filings, develop and implement HF / usability engineering processes to ensure compliance with regulatory requirements.
- Build relationships with the usability engineering communities and serve as a subject matter expert on global human factors regulations, standards, and best practices. Mentor, educate, and direct personnel on Human Factors-related activities and processes.
- Provide technical guidance and coaching of other engineers.
- Contribute to a dynamic start-up environment.
- Plans projects and ensures alignment with objectives and priorities and provides cross-functional communications.
- Supports strong collaborative relationships with external design/development, manufacturing partners and service providers.
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