Fresenius Medical Care North America Manager, Supplier Development Engineering in Ogden, Utah

PURPOSE AND SCOPE:

Provide leadership and guidance to the engineering team in their responsibility to deliver technical support to the North America Manufacturing and Global Strategic Procurement groups. Drive the engineering capability of the department to help meet organizational goals. Identify, recommend, develop and qualify new and alternative suppliers or materials for the North America Manufacturing Plants, in an effort to improve quality and/or reduce cost. Act as the primary technical lead and point of contact for the North America Manufacturing and Global Strategic Procurement groups in relation to North American products.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

  • Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.

  • Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.

  • Develops the technical and project management skills of the team. Ensures all direct reports are properly trained in design control, change control, and/or pharmaceutical change control procedures.

  • Assesses and allocates resources to approved projects.

  • Gains buy-in and approvals for new material/supplier qualification projects from appropriate plant, regional and/or global management.

  • Leads and executes all Design Control/Pharmaceutical Change Control requirements for material/supplier projects.

  • Acts as team/group leader, project manager, and technical expert for multiple long term projects with high scientific level.

  • Manages the development of design, conception, planning, tracking, and execution of multiple engineering projects with clear objectives and timely deliverables.

  • Interacts with other functions within the company including manufacturing, marketing, quality, GRD, regulatory, product lines and executive management.

  • Maintains good documentation practices for data forms, protocols, engineering/feasibility reports and laboratory notebooks.

  • Develops qualification test plans, protocols, and write qualification reports. Develops new test methods where necessary.

  • Conducts supplier quality audits and participate in the supplier qualification process.

  • Supports Strategic and Plant Procurement in negotiations.

  • Aligns priorities with global product lines and global procurement category strategies.

  • Prepares and presents to executive management project proposals, updates and other information as needed.

  • Maintains general housekeeping of working area and plant.

  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends changes to policies and establishes procedures that effect immediate organization(s).

  • Ensures compliance to corporate policies and local standard operating procedures as well as domestic and international standards.

  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

  • Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establish and maintain effective internal systems and controls to promote compliance.

  • Our Company Values: Honesty & Integrity, Quality, Respect & Dignity, Innovation & Improvement, Teamwork & Safety are the guiding principles of employee behavior at FMCNA.

  • Interacts with internal departments and external customers; particularly in problem resolution. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.

  • Provide technical guidance.

  • Assists with various projects as assigned by direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Regularly required to talk or hear. Frequently required to stand, walk and sit. Occasionally required to use hands and fingers to handle, reach with hands and arms; stoop, kneel, crouch, or crawl. Wear personal protective equipment that may include safety glasses, hearing protection, hair net and smock. Must occasionally lift and/or move up to 25 pounds.

  • Frequently exposed to moving mechanical parts and vibration. Occasionally exposed to wet and/or humid conditions; fumes or airborne particles; toxic or caustic chemicals; extreme cold; extreme heat and risk of electrical shock. The noise level in the work environment is usually quiet to loud.

  • May require up to 50% travel at times.

SUPERVISION:

Responsible for the direct supervision of various levels of Supplier Development Engineering staff.

EDUCATION :

  • Bachelor’s Degree required in Engineering, Master’s Degree preferred.

  • Lean Six Sigma Certification preferred.

EXPERIENCE AND REQUIRED SKILLS:

  • Minimum 6 - 8 years of manufacturing experience in an engineering function which includes supplier identification, evaluation, selection, and validation; 3+ years of supervisory or project/program management experience preferred.

  • Experience with broad base of commodities including electronics, metal fabrication, custom manufacturing equipment, electronics, plastics and chemicals, is desired. Medical device or pharmaceutical manufacturing experience preferred as well as working knowledge of ISO and CFR requirements as they pertain to medical devices and pharmaceutical manufacturing.

  • Thorough knowledge of process and material validations in a medical and pharmaceutical manufacturing environment.

  • Thorough knowledge of cGMP, CFR requirements and ISO standards applicable to pharmaceutical and medical device manufacturers.

  • Ability to lead and execute material/supplier qualification and cost reduction projects.

  • Ability to manage/lead and work effectively in a team oriented, highly complex, multi-site organization, including working with global counterparts, while maintaining a standard of world-class process excellence.

  • Outstanding people skills, with the specific ability to interact as a lead player.

  • Strong analytical problem solving skills and decision-making skills.

  • Must have exceptional multi-tasking ability time management skills.

  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.

  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations. Ability to apply mathematical operations to such tasks as frequency distribution and other statistical techniques, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

  • Knowledge of Project Management software; Spreadsheet software and Word Processing software. Ability to type 30 WPM.

  • Regular attendance and maintaining a good attendance record is an essential function of the job.

  • Reference ComplianceWire Curriculum.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity