Job Description

Job Description:
This position will lead the design control and human factors usability engineering support of patient-centric, safe, reliable, and innovative devices while providing subject matter guidance in Human Factors and User Risk Management to sub-team members. The position will work with the program lead to drive key activities throughout development phases of device and combination products, and facilitate the deliverables to support regulatory filing, product launch, and post-market surveillance.

Responsibilities:
1. Facilitating the design control process with integrated activities in risk management and human factors engineering for combination products. Makes decisions that require choosing between alternatives to resolve problems of moderate to high complexity; works predominantly within established procedures while introducing some new knowledge and methodologies. This position will work on both Life Cycle Management projects and on established products like Prefilled syringes and Auto-Injectors. The Life Cycle Management projects focus on changes to existing  products which require minor modifications; work on established products may involve generating new Design History File documentation as well as the creation and execution of an appropriate human factors usability plan for new combination products.
2. Support human factors engineering activities from user needs identification, writing of intended use and user requirements specification documents, formative usability assessments to final summative design validation studies for combination products. Applies technical and functional expertise to job related duties on most projects/ assignments within own group/project team.
3. Assist with project planning regarding Human Factors and User Risk Management activities. Generates internal or external documents/reports and presentations related to own work.
4. Engage in active collaboration with cross-functional groups. Ability to communicate human factors technical expertise. Participates in discussions and presentations in cross-functional meetings, presenting information to convey key messages.
5. Participation in regulatory filings and working with external collaborators. Continuing contribution to CMC teams, preparation of regulatory filings and working with external collaborators.

Qualifications:
1. Knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW.
2. Good understanding of new product introduction, design and development of extruded, molded and/or assembled device products.
3. Ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.
4. Good communication and collaboration skills; ability to connect with all levels of the organization; effective at working independently and seeking input when necessary.
5. Some experience working with third-party vendors for Human Factor Studies.
6. Develop, or review and approval of project design control documents, human factors study protocols, and reports.

Education:
Bachelor’s Degree (in engineering, human factors engineering, psychology or other relevant field) plus 4+ years’ experience in design control and human factors, user needs identification, risk management or related area; Master's Degree desirable.

Pay ranges between $72-84/hr based on experience 

Job Tags

Remote job, Contract work,

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