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Project Manager - Process Engineering in Ave Maria, FL ,  at Arthrex

Date Posted: 9/1/2018

Job Snapshot

Job Description

Requisition ID:
Project Manager - Process Engineering
Arthrex Manufacturing Inc
Ave Maria, FL

Main Objective:

The Project Manager’s will own scope, schedule, and cost of various high impact projects.  They serve as a fast response resource to resolve or mitigate problems and constraints and provide project management, technical guidance, and strategic direction to cross functional stakeholders in expediting execution of process improvement and validation activities.

Essential Duties and Responsibilities:

  • Identify opportunities for changing, improving and growing the business, align them with strategic imperatives and track to ensure business benefits are achieved.
  • Plan and execute lean transformation events targeting improvement of business performance on safety, quality, delivery, and cost.
  • Review and approve validation strategies, adoptions, protocols, and final reports for Operations.
  • Create systematic validation strategies and methodologies including definition of predicate devices to expedite equipment/process validations and leverage adoptions.
  • Develop requirements and provide plans for technology introductions.
  • Formalize strategies and rationales for product/process and tooling adoptions.
  • Generate and assess metrics for trends that affect quality and operational efficiencies.
  • Review process risk assessments and develop mitigation strategies. 
  • Schedule and plan equipment, process, tool, and software validations to exceed approved timelines and insure minimal disruption to production and expedite new product development and release.
  • Explore and recommend new and novel approaches to improve validation timelines.
  • Manage Master Validation matrices and supporting technical files in Agile PLM.
  • Implement systems to substantiate that preventive/unplanned maintenance maintains the validated state.
  • Coordinate with interdepartmental managers to insure efficient deployment of resources and technology.
  • Create procedures for developing variable inspection plans based on process capability.
  • Participate in development of SPC for shop floor processes.
  • Ensure timely disposition of non-conformances requiring validation review and release.
  • Report progress and status of validation projects to upper management and stakeholders.
  • Responsible for assessing validation impact from corrective actions related to non-conformances.
  • Support the product design process insuring expedited design transfer to manufacturing and ensuring process outputs meet functional and design specifications (inputs).
  • Support equipment change control process.
  • Participate in problem solving and triaging of issues with business/technical teams to drive root cause identification and resolution.  Participates in CAPA investigations and resolution.
  • Design and support FAT/SAT activities at vendor facilities as required.
  • Maintain a working knowledge of critical plant utilities, equipment, and software systems.
  • Supervise Engineers and Technicians to provide timely and efficient flow of services to stakeholders.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelor’s Degree in Engineering required.
  • 12+ years experience in a relevant engineering role required.
  • Medical Device Manufacturing or other FDA regulated industry required.
  • Experience validating the following processes preferred:  Final cleaning, In-process cleaning, passivation, laser marking, ultrasonic welding, automated /robotic assembly, manual assembly, weigh counting.
  • PMP certification preferred.
  • Scrum Master certification preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

  • Excellent communication skills and customer service orientation
  • Ability to handle multiple projects and work independently.
  • Advanced knowledge of regulatory requirements as they relate to qualification and validation activities.
  • Must have ability to interpret engineering drawings.
  • Must have working knowledge of statistical analysis and SPC.
  • Must have good communication and technical writing skills.
  • Knowledge of testing equipment and applicable national standards relating to testing. 
  • Familiarity with applicable FDA, ISO, AAMI, and EN specifications. 

Machine, Tools, and/or Equipment Skills:

PC, Microsoft Office, ERP software, proficient in Excel and database applications, Minitab or other statistical programs.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.