Product Development Engineer II - Upper Extremity

Enovis•Austin, TX

9d•Onsite

About The Position

The Product Development Engineer is a member of the R&D team and contributes to projects from proposal through final design and release. The role works with cross-functional teams to design and develop surgical instruments and implantable medical devices for Total Shoulder Arthroplasty, incorporating surgeon requirements and supporting new product development. Responsibilities include creating product designs and supporting documentation, developing concepts and mechanisms using 3D modeling, maintaining design history documentation, and ensuring compliance with FDA and ISO requirements and internal procedures. The engineer also supports project schedules and budgets, testing, prototyping, design reviews, and quality and process improvements. The position is primarily a resource role, with some leadership responsibilities, and involves collaboration with surgeons, customers, suppliers, manufacturing, supply chain, quality, marketing, regulatory, and engineering colleagues. Work may take place in office, manufacturing, mechanical testing, and cadaver-lab environments. Travel is less than 25%.

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 equivalent.
Ability to present information and respond to questions from managers, clients, and customers.
Ability to respond to 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 tasks such as frequency distributions, test reliability and validity, and statistical analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret technical instructions in mathematical or diagram form and work with abstract and concrete variables.
Knowledge of word processing, spreadsheet, internet, and contact/change management software.
Understanding of GD&T and its application to tolerance stacking activities.

Nice To Haves

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

Responsibilities

Participate as an active member of the New Product Development Team and contribute to projects from proposal through final design and release.
Identify and incorporate surgeon design requirements and product characteristics.
Coordinate with cross-functional teams, accept assigned tasks, and collaborate with or lead engineering personnel on project plans, designs, cost estimates, and specifications.
Create product designs and supporting documentation, including risk assessments, design reviews, verification and validation materials, drawings, test plans, manufacturing instructions, engineering change notices, and artwork.
Use 3D modeling to develop product concepts and mechanism designs; create detailed engineering drawings and release designs through the design change system.
Compile and maintain Design Dossiers or Design History Files, including design inputs, validation plans and reports, test protocols and reports, and design input/output matrices.
Ensure compliance with FDA and ISO regulations and internal procedures.
Establish and maintain project schedules and budgets; develop project plans using appropriate planning software and report progress to upper management.
Review designs for feasibility, accuracy, and technical soundness, and define and implement project testing requirements.
Participate in evaluating new concepts presented by surgeons or Enovis Surgical employees.
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; maintain communications with customers and suppliers.
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, such as SLA models or metal prototypes, and present designs for customer evaluation.
Use internal prototype-shop resources or external vendors to develop prototypes.
Maintain basic knowledge of competitive technologies and medical, clinical, technical, and biomedical developments in the field.