Product Development Engineer II - Upper Extremity

Enovis•Austin, TX

10d

About The Position

The Product Development Engineer – Upper Extremities participates in projects from proposal through final design and release. As a member of a cross-functional R&D team, the engineer designs and develops surgical instruments and implants for Total Shoulder Arthroplasty, working with product development, marketing, manufacturing, regulatory, and quality teams. The role includes creating product concepts and designs, developing prototypes and engineering documentation, defining and carrying out testing, maintaining Design History File documentation, and ensuring compliance with FDA and ISO requirements and internal procedures. The position also supports project planning, schedules, budgets, quality and process improvements, surgeon feedback activities, and communication with customers and suppliers. The role is primarily resource-focused, with 80% of time in a resource capacity and 20% in leadership activities.

Requirements

At least 4 years of design or development experience; engineering co-op or internship experience is strongly desirable.
Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
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, including exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to frequency distributions, test reliability and validity, and statistical analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide range of technical instructions in mathematical or diagram form and work with abstract and concrete variables.
Knowledge of word processing, spreadsheet, internet, and contact or change management software.
Ability to travel less than 25%.

Nice To Haves

Experience with 3D CAD packages, preferably SolidWorks or NX.
Experience in medical devices and/or orthopedics.
Experience working in a regulated industry.

Responsibilities

Participate as an active member of the New Product Development Team.
Identify and incorporate surgeon design requirements and product characteristics.
Collaborate with cross-functional teams, including Manufacturing Engineering, Purchasing, and Regulatory, and complete assigned tasks.
Create product designs and supporting documentation, including risk assessments, verification and validation activities, and design review documentation.
Use 3-D modeling to develop product concepts and mechanism designs.
Compile Design Dossiers or Design History Files and maintain required design documentation.
Ensure compliance with FDA and ISO regulations and internal procedures.
Establish and maintain project schedules and budgets.
Review designs for feasibility, accuracy, and technical soundness.
Define and implement project testing requirements.
Participate in evaluating new concepts presented by surgeons or other Enovis Surgical employees.
Collaborate with or lead other engineering personnel in developing project plans, designs, cost estimates, and specifications.
Prepare project documentation, including user needs, surgeon feedback and intellectual property documentation, engineering drawings, test plans, manufacturing instructions, design verification and validation documentation, engineering change notices, artwork, and other supporting 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 marketing and customers to develop conceptual designs, typically SLA models or metal prototypes, and present designs for customer evaluation.
Develop project plans using planning software and periodically report project progress to upper management.
Develop engineering drawings and CAD models, release them through the design change system, and apply GD&T in tolerance-stacking activities.
Coordinate prototype development through the internal prototype shop or external vendors.
Maintain basic knowledge of competitive technologies and medical, clinical, technical, and biomedical developments in the field.
Maintain communications with customers and suppliers.