Senior Manager, Machine Shop

Why Orthofix?

Guided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further.

How you'll make a difference?

The Senior Manager, Machine Shop is responsible for managing and assisting in all aspects of the custom and prototype machine shop. This includes interfacing with the Product Development teams, QA/RA/QE/QC, Marketing, and approved suppliers to producing engineering prototypes and special request devices.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• Performs duties associated with the manufacturing of implant and instrument systems

• Manages workflow through prototype machine shops, establish lead times, and drive the team and other departments to meet deliverable dates

• Provides firm leadership and appropriately delegates tasks to efficiently distribute workloads and nurture the growth of their subordinates

• Understands quality system regulations and strictly adheres to company implemented procedures

• Identifies and interfaces with various vendors to manufacture products

• Interfaces with cross-functional project teams (i.e. Quality, Regulatory and Marketing) from within and outside the organization and will require a resolve to do whatever it takes to complete the project within the regulations

• Assists with IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) for shop machinery and process if applicable

• Ensures machine shop is audit compliant (Internal and External)

• Manages production priorities and shop schedule

• Interfaces with Product Development and Marketing teams to manage custom and prototype jobs; runs weekly shop status meetings

• Maintains communication of dates and timelines for internal prototypes and customized devices

• Develops and maintains relationships with outside vendors to support machine shop workflow

• Hires, trains, develops and evaluates staff as needed and appropriate to support growth of business

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill, and/or ability required for this position.

Education/Certifications:

• High School Diploma or equivalent required

Experience, Skills, Knowledge, and/or Abilities:

• 10+ Years Medical devices

• Thorough understanding of machine shop principles and various manufacturing processes

• CAD/CAM experience preferred i.e. Pro-E, SolidWorks, Esprit, Mastercam

• Expert in interpreting engineering drawings

• Working understanding of FDA QSR and ISO-13485 principles

• Self-motivated team player

• Excellent communication and organizational skills to interact directly with engineers, machinists, and management

• Strong project management, mechanical and problem-solving skills

What qualifications are preferred?

The education, knowledge, skills, and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Bachelor's or Associates degree in technical field

Additional Experience, Skills, Knowledge, and/or Abilities:

• Ability to read Geometric Dimensioning & Tolerancing

• Experience in regulated field

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• Regularly required to bend, reach, stand, walk and sit daily.

• Frequently required to move objects weighing a minimum of 15 lbs.

• Frequently required to push or pull a rack or cart weighing a minimum of 50 lbs.

• Eyesight must be correctable to the level required to detect cosmetic and workmanship type defects such as wrong value components and solder shorts

• Control Precision - The ability to quickly and repeatedly adjust the controls of a machine to exact positions.

• Finger Dexterity - The ability to quickly respond (with the hand, finger, or foot) to a signal (sound, light, or picture) when it appears.

The anticipated salary for this position for an employeewho is located in Californiais$134,168to$191,381per year, plus bonus, and benefits.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, 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 over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), 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, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.