Senior Scientist, Drug​/Device Combo Products; Hybrid

Position: Senior Scientist, Drug/Device Combo Products (Hybrid)
** Job Description*
* ** Senior Scientist, Human Factors*
* The Human Factors team plays a pivotal role in combination product development (both design and process), commercialization, and lifecycle management. This person will lead and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in our company's portfolio and pipeline, including acquisition products.

This position will interact with all subject-matter experts within the Device Development team as well as with members of numerous internal cross-functional product development teams from concept through product launch and post-market surveillance. The Senior Scientist in this role will be responsible for performing and managing human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products.

** Key Responsibilities and

Activities:

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* + Perform and manage human factors activities throughout the whole product design and development cycle within the constraints of a regulated environment, including creating human factors plan, working with other disciplines to identify customer needs, intended use and potential hazard/harm, providing product and packaging design inputs/requirements, performing task and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need.

+ Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF, manage risk and ensure regulatory compliance

+ In collaboration with cross-functional colleagues, ensure the management and maintenance of records and databases that support regulatory compliance

+ Collaborate cross- functionally to support and maintain the internal HFE processes  to ensure consistency, efficiency and compliance

+ Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR).

+ Perform scientific literature reviews and database research on various topics independently and synthesize relevant information in support of  the human factors research Perform other job related duties or special projects as required.

*
* Qualifications:

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* + B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology plus three years of related experience or M.A/M.S. in one of the above disciplines.

+ Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.

+ Prefer to have experience in team and people coaching.

+ Excellent communication, leadership, and problem-solving skills.

+ Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

 eligibleforERP

PRD

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* Required Skills:

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* Analytical Method Development, Creativity, Data Compliance, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Pharmacology, Pharmacovigilance, Policy Compliance, Procedure Adherence, Product Development, Product Launch Planning

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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