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 in the United States, Europe and Latin America. Werepresent clients in all industries and all sizes. Our mission is to provideexceptional client and candidate experiences in order to get the best possibleresults. On behalf of our client, we are excited to present the following confidentialrole. We look forward to hearing from you and discussing the opportunity!

The Role:

This can be aREMOTE, HOME-BASEDposition!

Duties and Responsibilities:

• Leads and manages the MMS Engineering Statistician Team, this will include employee development, technical expertise development, hiring, staffing, and performance management.

• Collaborate with project/platform teams, plan and analyze studies/experiments; use statistical knowledge to support and guide business decisions. Recognized as the statistical leader among team members responsible for creating innovative strategies to enhance development programs.

• Assist project teams on data interpretation, inferences, data visualization and documentation of statistical results. Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, and non-engineers.

• Deep understanding of standards and regulations used to guide product development in the medical device industry. Working knowledge of 21CFR820.30, ISO 13485:2016 & integration of ISO14971:2019 risk management in the verification and validation of new designs and design changes in the post market.

• Keep abreast of new statistical developments and regulatory guidance; survey related fields for techniques that could be adapted to needs.

• Support engineering teams in issue/problem solving efforts, this involves the development of statistical analysis plans, use of robust design tools to discover, optimize and control key engineering parameters (e.g. Screening/modeling DOE’s for both linear and non linear outputs).

• Support the development of Reliability planning for development programs, including reliability goal creation, reliability allocation, training and execution of common reliability techniques which demonstrate reliability goal achievement.

• Responsible for overall creation, implementation, and maintenance of engineering statistical policies within the MMS business.

Requirements

• A Bachelor's degree (advanced degree strongly preferred) in statistics or applicable engineering discipline with at least 5 years of work experience with progressively increasing responsibility in the application of statistical techniques used in product development and design changes in a regulated environment.

• Direct people leadership / management experience leading technical professionals.

• Demonstrated competence in the application of statistical techniques used in areas such as R&D, manufacturing operations, quality, regulatory, and continuous improvement is a plus (examples of statistical techniques are, Basic Statistics, Tolerance Analysis, DOE, Functional Modeling, Reliability Modeling & Probability Analysis)

• Competent in experimental designs, sampling plans, equivalence studies, confidence and reliability testing and statistical analysis for test method evaluation among others.

• Knowledge in appropriate statistical software such as JMP, Minitab, & ReliaSoft in a regulated industry and/or experience with regulatory audits and certification management.

• Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization

• Demonstrated strong leadership skills and the ability to influence without direct authority are required within the function.

• Ability to create and deliver statistics training to non-statistical professionals is required.

• Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are essential. Collaborates well with non-statisticians.

Preferred:

• Designing processes and developing scripts (using R, Python, VBA, etc.) to perform and automate data analysis of large and complex datasets (e.g. data wrangling, text mining, statistical modeling, etc.). Computing, modeling and simulation skills using R, SAS, SPSS, JMP.

• Agile, Lean Six Sigma, Design for Six Sigma Product Development experience is a plus

• Proven successful project management leadership skills. Experience providing statistical consulting for non-statisticians is preferred.

• Experience working with FDA and/or other regulatory bodies outside of submission work is preferred (i.e. guidance document generation, meetings/clinics.)

Benefits

Ourclient offers 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