Sr. Manager, Manufacturing Engineering in Irvine, California at Orthofix

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 Sr. Manager - Manufacturing Engineering is responsible for leading new process development activities for all R&D and complex manufacturing projects. They will also lead the team supplying daily support to all areas of the Irvine Operation. The Sr. Manager will facilitate team development, budget, planning, and continuous improvement activities on an ongoing basis. The Sr. Manager will draw upon established expertise to help their team achieve solutions to a variety of complex technical problems. This role will work cross functionally across the entire organization in order to ensure projects and tasks are completed with high quality and on time.

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.

• Builds and develops engineering talent and teams.

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

• 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.

• Provides timely project updates to the leadership staff on a recurring basis.

• Generates and analyzes test data and reports to verify that designs meet functional and performance specifications.

• Stays current with industry standards by attending networking, training, or other developmental seminars.

• Interfaces with vendors regarding technical issues while supervising designs throughout the manufacturing process.

• Provides training, mentorship, and supervision to junior engineering and product development staff.

• Develops intellectual property based on developed products.

• Leads departmental meetings as scheduled.

• Performs other duties as assigned.

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:

• Minimum Bachelor’s Degree in Engineering

Experience, Skills, Knowledge and/or Abilities:

• 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.

• Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management.

What qualifications are preferred?

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

Education/Certifications:

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

Additional Experience, Skills, Knowledge and/or Abilities:

• Spine/Orthopedic device experience

• CAD experience (Pro-Engineer/Creo, SolidWorks, or equivalent)

• Human tissue processing

• Lyophilization experience

• Familiar with Aseptic processing

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.

• This position requires frequent exposure to chemicals and/or solvents.

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.

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.

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.