Associate Manager, Engineering

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?

As the Associate Manager on the Product Development team, you'll be responsible for overseeing a single - or small team of - individual(s) focused on bringing a variety of spinal implant and instrument systems from concept to market production.

You will work with engineering and marketing management to determine strategies and timelines associated with individual projects. This is a highly collaborative role, and you'll partner with Management, Marketing, Quality, Manufacturing, Operations, and 3rd party vendors/suppliers.

Responsibilities include technical design, project leadership, project team coordination, and personnel / multi-project management to address a variety of highly complex technical problems that require specialized knowledge. Work requires minimal supervision and draws upon extensive engineering experience and developing leadership abilities.

What will be your Duties and Responsibilities?

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Lead design projects to develop and commercialize medical implant & instrument systems. Coordinate cross-functional teams to complete project plans, product requirements, design & process specifications, verification & validation, and other DHF deliverables in accordance with Design Controls and Risk Management procedures.

• Manage Product Development Engineers and provide training, mentorship, and supervision to other junior product development staff.

• Create and launch design and development plans, verification, and validation plans for spinal implant and instrument-related projects within a design control environment.

• Work with vendors and the Operations team on technical issues while supervising spinal implant and instrument designs throughout the manufacturing process. Significant involvement in spinal implant and instrument system and process transfer to Manufacturing/Operations and ongoing support after commercialization.

• Effectively interact with cross-functional teams within Marketing, Purchasing, Quality, Manufacturing, and Operations to drive project plans and achieve project objectives.

• Support technical activities related to new and existing product spinal implants and instruments, process optimization, process and equipment troubleshooting, and process validation.

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

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

• Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations.

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

• Create standard operations procedures, standard test procedures, and other related records.

• Maintain a safety-first approach to process development and manufacturing.

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

• Attend, participate in, and lead departmental meetings as scheduled.

• Perform other duties as assigned.

What skills you'll need?

Education/Certifications:

• Bachelor's degree in Mechanical Engineering,

• Or, Biomedical Engineering (with included focus on mechanical design),

• Or Industrial Engineering (with included focus on mechanical design).

Experience, Skills, Knowledge, and/or Abilities:

• 5+ years of mechanical design experience.

• Strong knowledge of ASTM testing methodologies and test standards, and risk management and processes.

• Able to effectively communicate verbally and through written correspondence with all levels of peers and leadership at SeaSpine, surgeons, suppliers, etc.

• Proficiency with Creo, Solidworks, or similar CAD drafting software.

• Proficiency with MS Office, specifically Excel, and PPT.

• Able to work creatively, prioritize, and accomplish team goals and initiatives amidst competing priorities.

• Analytical mindset with strong attention to detail, and ability to problem solve and identify solutions in a high-growth and fast-paced environment.

NONESSENTIAL SKILLS, EXPERIENCE, AND QUALIFICATIONS

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

Education/Certifications:

• No additional requirements.

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

• ERP experience.

• Expertise in FDA QSR and ISO 13485 principles, including design controls and risk management.

• Experience performing and/or supporting spinal implant and instrument equipment and utility qualifications and validations.

• Strong understanding of spinal implant and instrument engineering fundamentals and technical knowledge of spinal implant and instrument materials, equipment, and supporting utilities.

• Demonstrated success in creating and maintaining design control documentation.

• Experience with medical device spinal implant and instrument/labeling equipment design/validation and manufacturing process development.

• Knowledge and understanding of FDA-regulated environment, package protocols, GMP, and ISO requirements.

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.

• Regularly required to sit for extended periods of time; frequently required to stand, walk, and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 35 lbs.

• Eyesight and hearing must be correctable to standard level.

The anticipated salary for this position for an employeewho is located in Californiais$116,416to$132,658per 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.