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?
Summary statement on overall purpose and function of the position.

Lead one or multiple projects within product development delivering innovative solutions to clinical problems. Collaborate with internal cross-functional groups and external surgeon consultants to successfully design and commercialize novel spinal implants and instrumentation systems. Conform to company quality and compliance policies while maintaining a high standard of work.

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.

• Design and commercialize medical device implant and instrument systems for spinal surgery.
• Coordinate cross-functional teams to complete project plans, product requirements, design and development specifications, verification and validation activities, and other DHF deliverables in accordance with FDA Design Controls and risk management procedures.
• Drive surgeon engagement and effective collaboration in order to generate product requirements and user inputs. Lead labs, calls, and most interactions with surgeon partners, both in cadaveric settings and field operating rooms.
• Create 3D models and detailed engineering drawings using CREO CAD software to develop new device design specifications and/or sustain existing systems.
• Prepare and execute testing and analyses to ensure that designs satisfy functional and performance requirements. Draft protocols, reports, technical memos, and other documentation in accordance with Quality procedures.
• Disseminate knowledge and program status clearly and effectively, translating complex issues to a variety of audiences (both engineering and non-engineering) on a regular basis. Must be comfortable and capable speaking in front of large groups, including the executive leadership team.
• Develop, manage, and maintain detailed project schedules and budgets.
• Interface with vendors to address technical questions and supervise designs throughout the manufacturing process.
• Engage with sales team partners and other field associates to support product development, marketing, and training activities.
• May manage or provide oversight to other team members and is expected to provide significant mentorship to junior engineers. Will be expected to be a "go-to" resource amongst peers, setting standards both technically and culturally.
• Must be capable of operating independently with little to no oversight.
• Perform other related duties as assigned.
• No immediate direct reports.

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.

• 6-10 years of experience
• Expert in modeling and drafting in CAD; CREO experience is mandatory, with exceptions requiring greater years of experience exemplifying the above duties and responsibilities of this role.
• Experienced in principles and application of linear FEA.
• Thorough understanding and ability to apply principles of GD&T. Practical experience driving inspection and manufacturing requirements through print specifications.
• Prior design experience utilizing medical materials, i.e. titanium alloys, stainless steels, etc.
• General knowledge of machining practices as it relates to design for manufacturability.
• Exceptional project management, time management, and soft skills required to effectively manage oneself and others.
• Familiarity with quality systems in a regulated industry.
• BSME or equivalent

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

• Experience designing spine hardware
• Basic understanding of biomechanics and human anatomy
• Ability to work with legal counsel to assure protection and maintenance of intellectual property

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 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.

The anticipated salary for this position for an employee who is located in California is $136,221 to $159,874 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.

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