Sr. Manager, Manufacturing Engineering

Orthofix Holdings, Inc.; Irvine (CA); On-site; USD 165,000 - 190,000; Full time

Benefits offered by this job

Bonus and benefits

Job summary

Orthofix Holdings, Inc. is seeking a Senior Manager – Manufacturing Engineering in Irvine, California. The role involves leading new process development for R&D and manufacturing projects. Qualified candidates will have over 10 years of experience in medical device manufacturing and a strong background in leadership and budget management.

The position offers a competitive salary ranging from $165,000 to $190,000 per year, plus bonuses and benefits. Candidates should possess a Bachelor’s degree in Engineering and expertise in FDA QSR and ISO 13485 principles. Preferred qualifications include a Master’s degree and CAD experience.

Qualifications

• 10+ years of experience in medical device manufacturing.
• At least 2 years of leadership experience.
• Ability to generate and maintain a budget.

Responsibilities

• Lead new process development activities for R&D.
• Facilitate team development and continuous improvement activities.
• Provide timely project updates to leadership.

Skills

Leadership experience

Budget management

FDA QSR expertise

ISO 13485 principles

CAD experience

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering (preferred)

Tools

Pro‑Engineer/Creo

SolidWorks

Job description

Senior Manager – Manufacturing Engineering

Responsibilities

• Lead new process development activities for R&D and complex manufacturing projects.
• Facilitate team development, budget control, planning, and continuous improvement activities.
• Apply Design Control and Risk Management procedures to establish project plans and product requirements.
• Collaborate with interdepartmental personnel and external partners to uphold project plans and achieve objectives.
• Provide timely project updates to leadership on a recurring basis.
• Generate and analyze test data and reports to verify that designs meet functional and performance specifications.
• Interface with vendors regarding technical issues while supervising designs throughout the manufacturing process.
• Provide training, mentorship, and supervision to junior engineering and product development staff.
• Develop intellectual property based on newly developed products.
• Lead departmental meetings as scheduled and perform other duties as assigned.

Required Qualifications

• Bachelor’s Degree in Engineering (minimum).
• 10+ years of experience in medical device manufacturing.
• At least 2 years of leadership experience, including hiring and coaching.
• Ability to generate and maintain a budget.
• Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management.

Preferred Qualifications

• Master’s Degree in Engineering (Biomedical or Mechanical preferred).
• Spine/Orthopedic device experience.
• CAD experience (Pro‑Engineer/Creo, SolidWorks, or equivalent).
• Human tissue processing and lyophilization experience.
• Familiarity with aseptic processing.

Physical Requirements / Working Conditions

Frequent exposure to chemicals and/or solvents; reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions of this position.

Salary: $165,000 to $190,000 per year (California), plus bonus and benefits.

Equal Employment Opportunity Statement

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, marital status, pregnancy, age (40 and over), protected medical condition, genetic information, disability, reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices, including recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.