Sr Engineering Supervisor, Extremities

Enovis•Austin, TX

11d•Onsite

About The Position

As a key member of the Research and Development Team, this role plays an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The Sr. Supervisor Engineering, Extremities will participate in all aspects of projects from proposal to final design/release by working cross-functionally across a product team consisting of product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants medical devices used in Total Shoulder Arthroplasty. This role also manages and develops lower level engineers and co-ops.

Requirements

A minimum of 6 years of design / development experience.
BS in Mechanical Engineering, Biomedical Engineering, or equivalent.
Experience with 3D CAD packages.
Ability to present information and respond to questions from groups of managers, clients, and customers.
Ability to apply advanced mathematical concepts and operations such as exponents, logarithms, quadratic equations, and permutations, as well as frequency distribution, determination of test reliability and validity, statistical analysis.
Ability to work in varying environments including but not limited to a Cadaver Lab, Mechanical Testing Lab, office setting etc.
Knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems.

Nice To Haves

Engineering co-op or internships are strongly desirable.
A minimum of 2 years of people management or mentorship is strongly desirable.
Experience working in a regulated industry preferred.
Experience in medical devices and/or orthopedics preferred.
Experience with 3D CAD packages (SolidWorks, NX preferred).

Responsibilities

Develop and manage lower level engineering personnel.
Participates as an active member of the New Product Development Team.
Identifies and incorporates surgeon design requirements and product characteristics.
Confers with cross-function teams (Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assigned.
Creates product designs and documentation used to substantiate those devices (risk assessments, verification / validation activities, design review documentation, etc.).
Uses 3-D Modeling to develop concepts and mechanism design (Solidworks).
Compiles Design Dossiers or Design History Files.
Assures compliance to FDA and ISO regulations and internal procedures.
Establishes and maintains project schedule and budget.
Reviews designs for feasibility, accuracy and technical soundness.
Defines and implements testing requirements associated with projects.
Participates in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees.
Collaborates / leads 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.
Works with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.
Participates in surgeon symposia, focus groups and surgeon consultant meetings.
Assists product development engineers and the Engineering Manager or Director of Shoulder Product Development with New Product Development projects.
Attends cadaver labs for learning purposes.
Works with both 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.
Maintains 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.
Develops project plans using appropriate planning software and periodically report on the progress of the project to upper management.
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.
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.
60% of time is spent in a resource capacity. 40% of responsibilities are in leadership activities.