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Manufacturing Engineer
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$101k-119k (estimate)
Full Time 1 Week Ago
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Pinnacle Transplant Techn is Hiring a Manufacturing Engineer Near Phoenix, AZ

Job Description

Job Description

About Us

Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patient’s quality of life through the processing and distribution of high-quality allograft implants. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

How You Contribute to Pinnacle Transplant’s Success

The Manufacturing Engineer is responsible for all manufacturing cleanroom environments, equipment, machines, fixtures, tools, jigs, and processes used to produce production human bone and tissue allografts in accordance with company SOPs, AATB standards, and federal and state government rules and regulations.

What You Will Do

Manufacturing Engineer – Consistently demonstrates proficiency to company standards in additional tasks

  • Lead 3-5 R&D NPD, new equipment, and/or process improvement projects including periodic management status reports and associated KPIs.
  • Create and maintain equipment capacity studies escalating and addressing conflicts to the 12-month S&OP Demand projections.
  • Create and maintain a campus layout plan contemplating future growth, new equipment, planned staffing levels, product and materials flow, and S&OP defined future production volumes and product mix.
  • Master and deploy Lean principles across all operations
  • Working knowledge of 6-sigma, GR&R, SPC, 8D, and other quality system concepts and tools.
  • Lead Processing Technician staff training materials relative to content, format, and presentation migrating from “Read and Understand” to photographic and video-based materials.

What Qualifications You Will Bring

  • Bachelor’s Degree in Engineering/Science (Biomedical, Chemical, or Mechanical Engineering preferred)
  • Minimum of 3 - 5 years of process or manufacturing engineering experience within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization
  • Minimum of 3 – 5 years of experience participating in process development, equipment qualifications, process validation protocols and reports, and executing validation protocols
  • Experience in applying statistical methods and lean manufacturing principles for product, process, and quality improvements.
  • Project Management experience is preferred.
  • Experience in design control and process validation, process capability, control, and monitoring analysis, root cause analysis, corrective and preventive action (CAPA), sterilization validation, and packaging validation is preferred.

Who You Will Partner With

  • Daily verbal and written communication with Operations leaders, R&D staff, and Finance.

Where You Will Work

  • Full Time position (40 hours or more) based in Arizona. Hours may include evenings and weekends to perform tasks outlined in the job description.
  • Duties are such that there will be contact with human tissue and bone which may be considered infectious; use of PPE is required in all work areas.
  • Work periodically requires standing for extended periods of time.

Benefits/Total Rewards

  • Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date
  • Company-Paid Short and Long-term Disability Insurance
  • Company-Paid Identity Theft Protection
  • Company-Paid Life Insurance Policy of $50,000
  • 401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of
  • employment
  • Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance

Paid Time Off:

Paid time off is prorated based on quarter hired:
  • Quarter 1: 160 hours
  • Quarter 2: 120 hours
  • Quarter 3: 80 hours
  • Quarter 4: 40 hours

(1) week paid sick time, accrued per pay period beginning after 90-days of employment

(10) annual paid holidays

Job Summary

JOB TYPE

Full Time

SALARY

$101k-119k (estimate)

POST DATE

06/18/2024

EXPIRATION DATE

07/05/2024

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The following is the career advancement route for Manufacturing Engineer positions, which can be used as a reference in future career path planning. As a Manufacturing Engineer, it can be promoted into senior positions as an Industrial Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing Engineer. You can explore the career advancement for a Manufacturing Engineer below and select your interested title to get hiring information.

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