Position Title:Engineering Manager
Location: Carlsbad
Position Type: Full time


Description:

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 Manager, Engineering will facilitate team development, budget, planning, and process improvement activities on an ongoing basis. They are responsible for overseeing multiple high-level project team activities to develop concurrent and highly technical medical device systems from concept through market introduction and field support in accordance with FDA and ISO requirements. The Engineering Manager will draw upon established expertise to help their team achieve solutions to a variety of complex technical problems.

What will be your Duties and Responsibilities?

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

• Oversees individuals leading design projects to develop and commercialize complex medical implant and instrument systems. Establishes project plans, develop product requirements, and coordinate other team activities in accordance with Design Control and Risk Management procedures

• Effectively interacts with interdepartmental personnel and external partners to uphold project plans and achieve project objectives

• Supports strategic plans for process and plant improvements to increase efficiency and manage costs

• Generates complex implant and instrument CAD models and detailed engineering drawings using CAD software to develop new device designs and/or maintain existing products

• Supervises spinal implant and instrument designs throughout the manufacturing process

• Participates in spinal implant and instrument system and process transfer to Manufacturing and Operations and on-going support after commercialization

• Supports the evaluation and onboarding of new manufacturing partners

• Effectively interacts with cross-functional teams within Marketing, Purchasing, Quality, Manufacturing, and Operations

• Drives and supports process optimization, process and equipment troubleshooting, and process validation improvement initiatives

• Supports investigations relating to spinal implant and instrument issues, product release performance, and/or customer issues

• Identifies spinal implant and instrument projects to improve yield, lower costs and improve efficiency

• Partners with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for operations

• Creates standard operations procedures, standard test procedures, and other related records

• Maintains a safety-first approach to process development and manufacturing

• Engages with surgeons, Sales team partners, and other field associates to support product development, marketing, and training activities

• Works generally independently and some elements may be shared with senior engineering management

• Attends, participates in, and leads departmental meetings as scheduled

• Performs other duties as assigned

What skills you'll need?

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

Education/Certifications:

• Bachelor’s Degree in Engineering

Experience, Skills, Knowledge and/or Abilities:

• 5+ years’ experience in medical devices (Spine/Orthopedic device preferred)

• Demonstrated ability leading teams and completing several projects on time and on budget with minimal supervision

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

• CAD experience required (Pro-Engineer/Creo, SolidWorks, or equiv.)

• Strong computer skills are required including proficient and accurate usage of CAD software (Pro-Engineer/Creo preferred), word processing (Word), spreadsheets (Excel), charting, flow charting, and graphs

• Ability to utilize a computer, telephone, fax, scanner, and copy machine as well as other general office equipment

What skills 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 Degree in Engineering (Biomedical or Mechanical)

Additional Experience, Skills, Knowledge and/or Abilities:

• 9+ years’ experience in medical devices (Spine or Orthopedic device)

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.

• No additional physical requirements or essential functions for this position

The anticipated salary for this position for an employee who is located in California is $150,216 to $180,537 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.

About Us:

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.

Equal employment opportunity, including veterans and individuals with disabilities.

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