Senior Product Development Engineer

2 days ago

Austin, Texas, United States DJO Global Full time
Job Description:

As a Senior Product Development Engineer, you will play a key role in the design and development of surgical instruments and implants for medical devices used in Shoulder Arthroplasty. You will work closely with a cross-functional product team to create innovative solutions that meet the needs of surgeons and patients.

Key Responsibilities:
  • Participate in the design and development of new products, including identifying and incorporating surgeon design requirements and product characteristics.
  • Collaborate with cross-functional teams, including manufacturing, purchasing, and regulatory, to ensure compliance with FDA and ISO regulations.
  • Develop and maintain project schedules and budgets, and ensure timely completion of projects.
  • Review and validate designs for feasibility, accuracy, and technical soundness.
  • Develop and implement testing requirements associated with projects.
  • Collaborate with other engineering personnel to formulate project plans, designs, cost estimates, and specifications.
  • Assure proper preparation of documentation, including user needs, surgeon feedback, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork, and other supporting engineering documents.
  • Work with manufacturing, supply chain, and quality assurance to review and monitor quality and process improvements for new product development.
  • Participate in surgeon symposia, focus groups, and surgeon consultant meetings.
  • Assist product development engineers and the Engineering Manager or Director of Shoulder Product Development with new product development projects.
  • Attend cadaver labs for learning purposes.
  • Work with the marketing team and customers to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to the customers for evaluation.
  • Maintain all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
  • Develop project plans using appropriate planning software and periodically report on the progress of the project to upper management.
  • Develop detail engineering drawings, CAD modeling, and release through design change system; understand GD&T and apply it in tolerance stacking activities.
  • Work through internal prototype shops or contract through external vendors on developing prototypes.
  • Maintain basic knowledge of competitive technologies, in addition to medical, clinical, technical, and biomedical developments in the field.
  • Maintain communications with customers and suppliers.
  • Relies on instructions and pre-established guidelines to perform the functions of the job.
Minimum Basic Qualifications:
  • A minimum of 5 years of design/development experience; engineering co-op or internships is strongly desirable.
  • BS in Mechanical Engineering, Biomedical Engineering, or equivalent.
  • Prior knowledge of and experience with Word Processing software; spreadsheet software; internet software; contact/change management systems.
  • Prior experience with 3D CAD packages (SolidWorks preferred).
Desired Qualifications:
  • Experience in medical devices and/or orthopedics preferred.
  • Experience working in a regulated industry preferred.
  • Ability to 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.
Travel Requirements:

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