Program Manager - Enabling Technologies

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?
Interfaces with all areas affected by the project portfolio, particularly in medical device software, hardware, and system development for spine, orthopedic, and neurosurgical applications. Ensures adherence to procedures and quality standards, such as ISO 13485, 21 CFR 820, and EU MDR.  Coordinates product development for Enabling Technologies across multiple business units, driving medical device software/hardware/system integration and cross functional execution. Partners with software and hardware engineering, quality and regulatory (Q&R), R&D, marketing, and operations to ensure timely delivery within budget in alignment with the business unit objectives.  with the business unit objectives. Provides status of the project portfolio to the various leadership teams. Guides New Product Innovation from original concept through final implementation, commercial release and post market acceptance.

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 as tasks as needed and assigned.

• Ensure all necessary inputs of the projects from the portfolio, including business case completeness and approval, cost targets and resource allocation are completed prior to project kickoff.

• Advise organization leadership on the status and resource planning of the project portfolio.

• Plan, direct, and ensure successful management of designed business solutions utilizing the complete resources of the Project Management function.

• Creation and management of master project portfolio schedule and budget.

• Identification and development of project management methodology, best practices and standards.

• Development and management of project policies, procedures, templates and other shared documentation.

• Coordination of communication planning across project portfolio.

• Monitoring compliance with project management standards, policies, procedures and templates through project audits.

• Leadership of high-priority projects requiring considerable resources and high levels of functional integration.

• Coaching, mentoring, training and development of project management personnel.

• Assessing resource load and making appropriate individual assignments of project management personnel.

• Management of stakeholder communications.

• Define and monitor appropriateness of Key Performance Indicators.

• Generation of reporting on program performance through key performance indicators and oversight of reporting on project performance

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.

In addition to strong project management skills, the successful individual must have solid knowledge of business principals and concepts, product development, marketing, manufacturing operations, and the sales process of medical products as well as understand how to leverage opportunities across the portfolio. Qualifications and skills of the Program Manager include the ability to lead and motivate, encourage teamwork, to communicate effectively with all levels of the organization, to anticipate and identify critical technical obstacles, and to make accurate operational decisions. This individual must have a background sufficient to understand issues that may present an impact on strategic business objectives, both as threats and as opportunities. In order to facilitate effective change management, the program manager must be well-versed in proactively seeking out stakeholders for development and implementation of activities that will improve the ability of the organization to execute projects successfully. The successful candidate will have the skills, experience, and qualifications required to:

• Ensures adherence to procedures and quality standards, such as ISO 13485, 21 CFR 820, and EU MDR. 

• Manage changes to the program, master schedule, and department budget using appropriate verification techniques in order to keep the project portfolio accurate, updated, and reflective of authorized program changes.

• Achieve synergies and identify dependencies across multiple business units to maintain accurate timelines and budgets

• Measure program performance using appropriate tools and techniques in order to monitor the progress of the project portfolio, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.

• Implement and/or supervise the approved actions and workarounds required to mitigate program risk events in order to minimize the impact of threats on the project and take advantage of opportunities.

• Document high-level risks, assumptions, and constraints using historical data and expert judgment in order to understand program limitations.

• Demonstrate skill in organizing resources and establishing priorities.

• Develop, plan, and implement short- and long-range goals.

• Provide group facilitation, mediation, and conflict resolution skills.

• Analyze complex problems, interpret functional needs, and develop integrated, creative solutions.

MINIMUM QUALIFICATIONS

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

Education/Certifications:

• Possess a Bachelor of Science or higher degree in relevant engineering, business, or technical field.

Experience, Skills, Knowledge and/or Abilities:

• Five or more years of experience leading projects/programs in a medical device, biomedical or high technology industry.

• Eight or more years of project/program management experience.

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:

• Project Management Institute – Project Management Professional certification.

Additional Experience, Skills, Knowledge and/or Abilities:

• Experience working with cross-functional teams composed of a variety of engineering disciplines (to include electrical, mechanical, and software) and manufacturing technologies.

PHYSICAL DEMANDS AND WORK CONDITIONS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Periodic travel (up to 25%) may include trips to meet with vendors, manage joint development partnerships, engage customers including surgeons, observe surgical procedures, interface with satellite corporate facilities, participate in cadaver studies or workshops, and attend trade shows

• Eyesight should be correctable to standard passing level.

• Sitting, standing, bending frequently. 

• Able to function in operating room and lab environments.

• Utilize computer system ‑ 70% daily.

• Phone usage - daily.

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.