Surgical Senior Product Development Engineer II

Company: DJO
Location: Austin
Posted on: August 6, 2022

Job Description:

Job DescriptionSr. PDE II / Engineering Supervisor-In-Training Job Description Summary:In order to facilitate the achievement of company goals, the Sr. PDE II will lead, manage, and ensure the successful completion of the development of products as defined by the company. This includes mentoring team performance and ensuring that the engineering team is operating effectively to achieve set objectives, participating in cross-functional development teams and collaborating with the business leadership to execute projects from concept through commercialization. The Sr. PDE II is also responsible for managing internal and external design, development, testing, and manufacturing suppliers and defining and managing the product development scope of work to ensure product safety, quality, performance, and cost requirements are met.Job Description

• Lead a team of biomedical engineers, mechanical engineers and engineering technician(s) either direct or indirect, in developing and bringing to market, new innovative medical products, that provide true advances in clinical outcomes by:
  • Identifying and documenting surgeon requirements and product characteristics
  • Conferring with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing, and Regulatory); accepts and completes tasks as assigned
  • Creating product designs and documentation used to substantiate those devices (i.e. risk assessments, engineering specifications, verification / validation activities, design review documentation, etc.)
  • Using 3-D Modeling to develop concepts and mechanism design (i.e. Solidworks)
  • Compile Design Dossiers or Design History Files
  • Assuring compliance to FDA and ISO regulations and internal procedures
  • Establishing and maintaining project schedule and budget
  • Reviewing designs for feasibility, accuracy and technical soundness
  • Defining and implementing testing requirements associated with projects
  • Participate in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees.
  • Collaborate / lead other engineering personnel in formulating project plans, designs, cost estimates, and specifications.
  • Assures proper preparation of documentation as required per project plans including user needs, surgeon feedback / IP, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documents.
  • Working with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.
  • Identify new design methods and materials to improve productivity and competency within Product Development team.
  • Ability to lead product development engineers and assists the Engineering Manager of Knee Product Development with New Product Development projectsAdditional Job Description
    • Assist with administration of personnel functions, including:
      • Monitoring of team member capabilities to drive project task efficiencies
      • Hiring and mentoring of engineers and support personnel in product development team
      • Identify the need for and assist with hiring of new personnel
      • Analyze and recommend resources needed to meet project goals
      • Train new department employees on department procedures, work instructions, forms, and any other aspect that will affect their responsibilities
      • Contribute to the intellectual property position of the company via invention and patent applications.
      • Maintain basic knowledge of competitive technologies, in addition to medical, clinical, technical and biomedical developments in the field.
      • Maintain communications with customers and suppliers.
      • Assist and support other employees and teams as necessary.
      • Other responsibilities assigned by manager including attending trade shows, surgery and other corporate functions associated with role as an Sr PDE II.
      • Be aware of and comply with regulatory requirements that are applicable to Enovis Surgical, including but not limited to 21CFR820 & other MDR regulations as applicable.
      • Develops detail engineering drawings, CAD modeling and release through design change system; understands GD&T and can apply it in tolerance stacking activities
      • Works through internal prototype shop or contract through external vendors on developing prototypes.
      • Schedules and directs product team meetings as needed in the absence of engineering management, assuring timeliness of project execution
      • 60% of time is spent in a resource capacity, 40% of responsibilities are in leadership activitiesCompetency
        • To perform the job successfully, an individual should demonstrate the following competencies:
          • Analytical - Synthesizes complex or diverse information
          • Leadership - Able to "own the room" and lead discussions with the internal project team(s), Enovis leadership, and customer meetings
          • Design - Demonstrates attention to detail; able to create design solutions to mechanical problems
          • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics
          • Project Management - Communicates changes and progress
          • Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills
          • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification
          • Written Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information; writes detailed test protocols/reports
          • Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
          • Business Acumen - Understands business implications of decisions
          • Diversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environment
          • Judgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making process
          • Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properlyQualifications
            • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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 functionsEducation / Experience
              • 8+ years of design / development experience
              • BS in Mechanical Engineering or equivalent
              • Experience in medical devices and/or orthopedics preferred
              • Ability to effectively present information and respond to questions from groups of managers, clients, and customers
              • Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community
              • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
              • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysis
              • Ability to define problems, collect data, establish facts, and draw valid conclusions
              • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
              • To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems
              • Experience with 3D CAD packages (SolidWorks preferred)Work Environment
                • While performing the duties of this job, the employee is exposed to the manufacturing environment
                • While performing the duties of this job, the employee is exposed to the office environment
                • Employee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver lab
                • The noise level in the work environment is usually moderatePhysical Demands
                  • While performing the duties of this job, the employee is regularly required to sit, talk, and hear
                    • The employee frequently is required to sit and use hands to operate computer keyboard, and telephone.
                    • The employee is frequently required to stand, walk, and reach with hands and arms
                    • This position works in a typical office/manufacturing/warehouse environment
                    • The employee must occasionally lift and/or move up to 30 pounds
                    • The noise level in the work environment is usually moderate
                    • This position works in a typical office environment
                    • Perform job duties for 8 or more hours a day
                    • Specific vision abilities required by this job include close vision, color vision, and ability to adjust focusAbout Djo GlobalDJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast -, Chattanooga, CMF---, Compex -, DonJoy -, ProCare -, Exos---, Dr. Comfort -, DonJoy Performance - and DJO - Surgical.For Additional Information On The Company, Please Visit Www.DJOglobal.com.DJO is a growing subsidiary of diversified technology leader Colfax CorporationEOE AA M/F/VET/DisabilityAll qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

Keywords: DJO, Austin , Surgical Senior Product Development Engineer II, Engineering , Austin, Texas