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 ResponsibilitiesIndependently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instrumentsDevelops 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 teamManages the development of working prototype models to be used for project design evaluationGenerates protocols for testing and analyzing new and current productsGenerates 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 vendorsLeads and/or serves on cross-functional product development teams responsible for new product development from concept through product launchProvides technical input to marketing counterparts on the development of collateral marketing materialsProvides technical expertise to marketing and sales as to intent of design functionProvides technical experience to Regulatory Affairs to support FDA 510K submissionsCreates and processes Engineering Change Orders (ECO's)Other duties as assigned.
RequirementsThe 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 SolidworksExperience with phase gate design control processesDemonstrated 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 functionsLeadership{​{​{​{:
}}}} a demonstrated ability to lead people and get results through othersAbility to think strategically, evidence of innovative thinking and high energyProven participation and leadership with cross-functional core teamsA full and complete knowledge of the medical marketplace and the ability to continuously evaluate trends and adjust strategy to compensate and take advantage of shiftsExpert experience in product design procedures and project development methodology in the medical device industryStrong technical skills in product development.
Ability to evaluate the designs of direct reports to assure technical excellenceStrong analytical skills and creative problem-solving skillsExtensive experience of manufacturing methods including machining, sheet metal, injection molding and electronic device manufacturing. Experience in sterile disposable devices a plusKnowledge in the use and interpretation of geometric dimensioning and tolerancingStrong verbal and written communication skills; comfortable presenting to senior management1+ years of supervisory experience Supervisory ResponsibilitiesDirectly supervises Product Development Engineering team. Education And ExperienceUndergraduate 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 RangeAlphatec 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
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