Orthofix

Orthofix

Sr. Manager, Manufacturing Engineering

Irvine · Senior

Sponsorship not specified$165k-$190kDetected 31 days ago
Intellectual PropertySolidWorksCreoFDA RegulatoryMedical DevicesLeadershipMentoring

About the role

  • Manager - Manufacturing Engineering is responsible for leading new process development activities for all R&D and complex manufacturing projects.
  • Manager will facilitate team development, budget, planning, and continuous improvement activities on an ongoing basis.
  • Manager will draw upon established expertise to help their team achieve solutions to a variety of complex technical problems.

Responsibilities

  • Builds and develops engineering talent and teams.
  • Establishes project plans, develops product requirements, and coordinates other team activities in accordance with Design Control and Risk Management procedures.
  • Effectively collaborates with interdepartmental personnel and external partners to uphold project plans and achieve project objectives.
  • Generates and analyzes test data and reports to verify that designs meet functional and performance specifications.
  • Interfaces with vendors regarding technical issues while supervising designs throughout the manufacturing process.
  • Develops intellectual property based on developed products.
  • Leads departmental meetings as scheduled.
  • Performs other duties as assigned.

Requirements

  • Minimum Bachelor's Degree in Engineering

Nice to have

  • Master's Degree in Engineering (Biomedical or Mechanical preferred)

Skills

  • 10+ years' experience in medical device manufacturing.
  • At least 2 years of leadership experience, inclusive of hiring and coaching experience.
  • Ability to generate and maintain a budget.
  • Spine/Orthopedic device experience
  • CAD experience (Pro-Engineer/Creo, SolidWorks, or equivalent)
  • Human tissue processing
  • Lyophilization experience
  • Familiar with Aseptic processing

Compensation

  • The anticipated salary for this position for an employee who is located in California is $165,000 to $190,000 per year, plus bonus, and benefits.

Benefits

  • Leads business critical design projects to develop and commercialize Orthobiological medical products and devices.

Visa & Work Authorization

  • and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and

This listing is sourced directly from Orthofix's careers page and normalized into a canonical job model.