Project Manager - Madison Wisconsin Area

Reports to:     SVP Operations                                              Location:        Madison Area, WI

Job Summary

This Project Manager will help organize, manage, and plan complex projects for the organization’s research, development, and product implementation efforts. 

Responsibilities

  • Monitors and manages customer complaint management system.
  • Leads an interdepartmental team to complete an assigned project on time, to specifications, and with accuracy and efficiency.
  • Outlines the tasks involved in the project and delegates accordingly.
  • Conducts cost analysis, estimating expected costs for the project.
  • Prepares and implements a budget based on estimates.
  • Conducts risk assessments; reports identified risks to management; provides recommendations for mitigation of risk (including termination of the project if appropriate).
  • Ensures products manufactured meet company established specifications by enforcing SOP’s, DMR’s, and cGMP standards as required by the Quality Systems Regulations – CFR 820 and ISO 13485 regulations.
  • Addresses questions, concerns, and/or complaints throughout the project.
  • Acts as a liaison between company, customers, and vendors.
  • Communicates and collaborates with sales and marketing teams to provide training and information required to promote and sell new projects, programs, and systems.
  • Ensures compliance with federal, state, local, industry, contractual, and company regulations, standards, specifications, and best practices.
  • Performs other related duties as assigned.
  • Ensures DMRs and BOMs are kept up to date, including processing of change orders as needed.

 

Qualifications / Requirements / Experience

  • Bachelor’s degree in Mechanical or Electrical Engineering, Masters preferred
  • Must have 7+ years experience with 5+ years directly in manufacturing in Medical Device Industry
  • Medical Device Experience including FDA 21 CFR Part 820
  • PMP, PgMP, CAPM or comparable PM Certification
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Strong supervisory and leadership skills.
  • Ability to prioritize tasks and to delegate them when appropriate.
  • Thorough understanding of or the ability to quickly learn about the project or product being developed.
  • Proficient with Microsoft Office Suite or related software with fluency in MS Project program

 

Specific Criteria:

  • Based in Madison, Wisconsin Area
  • Monday – Friday, 9am – 5pm


EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc