KP Recruiting Group is a consulting firm that providesleadership and exceptional talent to some of the world’s leading companies.Headquartered in the Midwest, KP Recruiting Group has successfully completedcountless engagements across the United States. We represent clients in allindustries and all sizes. Our mission is to provide exceptional client andcandidate experiences in order to get the best possible results. On behalf ofour client, we are excited to present the following confidential role. We lookforward to hearing from you and discussing the opportunity!

The Role:

The Clinical Human Factors Manager has responsibility for generation of evidence supporting claims of products. He/she is responsible for developing, supervising, executing and reporting of studies (clinical trials and Human factors studies in compliance with policies and procedures, to contribute to Medical Devices development. He/she participate in core teams to represent Medical Affairs in development phases when a study is in preparation.

RESPONSIBILITIES:

The CHFS responsibilities for managing studies for the allocated products under development includes the following:

• Writing and updating the Clinical Development Plan (CDP)

• Contributing to task analysis, use FMEA, IFU building and validation

• Contributing to developing evaluation of products (methods and capabilities) to assess end-users acceptance, preference and willingness to adopt the medical device

• Building study design based on validated CDP

• Establishing an appropriate budget and timeline for the study with input from the corresponding project core team

• Working with his/her line manager to ensure support from C&HF expert team members to get support for various element of the study, and with other piers e.g. Statistician to design the study

• Ensuring appropriate selection, evaluation of proposals, and once the supplier chosen, training of study supplier; acquire signed supplier documents (contract) within study timelines, up to the approval of final payments

• Establishing investigational products specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally) and supervising the preparation of the corresponding products on time and in compliance with defined budget

• Maintaining study documentation

• Completing final study report and closing of study file, contributing to publication writing Clinical studies may range from simulated use studies (employing a patient or health care worker to use the device in a simulated environment; e.g. Human Factor studies) to complex studies in human subjects that may include drug/device combinations.

The CHFS interacts with product core teams and members:

• Represents Medical Affairs in several core team and cluster handling new product development

• Is accountable to the core team leader for deliverables of the Medical Affairs function

• Leads the overall planning, leadership and execution of all activities related to Medical Affairs function

• Provides work direction to the product safety and clinical development extended team members with direction in regards to the project

• Estimates resources requirement and identifies resources in conjunction with functional managers

• Ensures deliverables produced by Medical Affairs function meet the appropriate quality standards

• Communicates progress and facilitates decision making with the core team and Medical Affairs function

• Prepares and delivers presentations covering relevant Medical Affairs information (functional capabilities and clinical and HF study data) to customers during TC and face to face customer meetings

Additional Responsibilities:

• The CHFS is responsible for assuring that study is conducted with HF guidelines (HF studies) and all National and Local Regulations.

• The CHFS participates in establishment and updating of the SOPs related to the C&HF development activities.

• The CHFS is also expected to attend and complete assigned training courses concerning medical devices and human factors.

• It is expected that the CHFS acts as a leader of the Medical Affairs department, and mentors other individuals formally or informally.

• The CHFS is expected to set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and guiding principles.

• The CHFS is expected to contribute as required to cross department and corporate initiatives, and to share their expertise.

Requirements

• Education Scientific background, (Biomedical Engineering, Masters or PhD in Biological Sciences, or PharmD preferred)

• Experience 3 years of preferably simulated studies experience, within the Pharmaceutical or the Medical device industry, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good understanding and operational knowledge of national regulations and a good understanding of international regulations.

Benefits

Our clientoffers a comprehensive benefits package including:

401kMatching

Family andIndividual Insurance Packages (Health, Life, Dental, and Vision)

Paid TimeOff & Paid Holidays

Long &Short-Term Disability

IdentityTheft Plans

Retirement& Pension Plans

EmployeeAssistance Program

EmployeeReferral Program

TuitionReimbursement Programs

Advancement& Professional Growth opportunities 

ParentalLeave

& More