Manager, Development - Advanced Technology

Looking for a hands-on technical Manger to support product development by leading an engineering team focused on developing innovative technologies for the spine market.  This individual will have ultimate responsibility for the execution of the team they lead, and delivery of products to market. Involved in identifying opportunities for innovation, enhancing the company’s existing products and determining product end of life, while also driving deeper engagement within the engineering department towards the organization’s top priorities. Additional responsibilities include identifying ways to streamline the new product development process and enhancing cross functional relations to ensure we are driving procedural efficiencies across departments. This role will be responsible for the technical and professional growth of the engineering team that they lead. This role will have direct surgeon interactions.

Essential Duties and Responsibilities

• Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments.
• Develops the technical skills and directs the professional growth of an engineering team.
• Leads the development of new products and manufacturing processes and/or serves as a leader of a project team.
• Manages the development of working prototype models to be used for project design evaluation.
• Generates protocols for testing and analyzing new and current products.
• Generates design assurance documentation for the project Design History File (DHF).
• Develops quality control procedures and inspection methods
• Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
• Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch.
• Provides technical input to marketing counterparts on the development of collateral marketing materials
• Provides technical expertise to marketing and sales as to intent of design function.
• Provides technical experience to Regulatory Affairs to support FDA 510K submissions.
• Creates and processes Engineering Change Orders (ECO’s)
• Other duties as assigned.
  

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience with 3D CAD system, preferably Solidworks
• Experience with phase gate design control processes
• Demonstrated success in leading cross-functional product development teams from concept through product launch, including demonstrated planning, organizing and time management skills. 
• Ability to work with other disciplines in a cross functional core team including software, firmware, electrical, systems, regulatory and quality functions.
• Leadership: a demonstrated ability to lead people and get results through others
• Ability to think strategically, evidence of innovative thinking and high energy
• Proven participation and leadership with cross-functional core teams
• A full and complete knowledge of the medical marketplace and the ability to continuously evaluate trends and adjust strategy to compensate and take advantage of shifts
• Expert experience in product design procedures and project development methodology in the medical device industry.
• Strong technical skills in product development.  Ability to evaluate the designs of direct reports to assure technical excellence.
• Strong analytical skills and creative problem-solving skills
• Extensive experience of manufacturing methods including machining, sheet metal, injection molding and electronic device manufacturing.  Experience in sterile disposable devices a plus.
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing
• Strong verbal and written communication skills; comfortable presenting to senior management
• 1+ years of supervisory experience 

Supervisory Responsibilities

Directly supervises Product Development Engineering team.

Education and Experience

Undergraduate degree in Mechanical or Biomedical Engineering or related field, Graduate degree preferred.  7-10 year’s experience as a Product Development Engineer or similar role and 1 year minimum supervisory experience. Experience with product design using 3D CAD system, phase gate design control processes, cross-functional product development team experience, manufacturing methods for use with metal and plastic material inputs, and geometric dimensioning and tolerancing. Collaboration experience with multidisciplinary teams and a full understanding of the product development, marketing function, operating room specialties and procedures, and a successful history capturing market share. Prior successful development and launch of medical products through full lifecycle also required.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $145,000 to $170,000 Full-Time Annual Salary