Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.
Job Description:
The Sr. Design & Development Engineer is responsible for leading all phases of the product development process for Confluent's Complex Catheter Center of Excellence in Austin, Texas. The qualified candidate will be expected to work directly with customer and internal engineering, project management, sales, and leadership teams to develop design inputs and project plans, generate design concepts and prototypes, create engineering specifications, identify and work with suppliers, build and evaluate product and production fixturing, specify and order equipment, lead design and process verification and validation, lead pilot production activities and training, produce documentation according to FDA design control requirements in a design history file (DHF), support regulatory submissions, and transfer products to production. The Sr. Design & Development Engineer may function as an individual contributor or lead a small cross-functional team of engineering, operations, and quality staff members to work within the constraints of budget, schedule, and scope while managing risk and ensuring adherence to established processes and regulations.
Job Roles and Responsibilities:- Understands and adheres to principles of FDA Design Control (FDA 21 CFR 820.30) and Quality Management Systems (ISO 13485) for product development
- Uses project management tools to manage individual and team-based medical device development projects
- Works with project managers to plan and schedule activities necessary to meet project timelines
- Develops device input requirements and engineering specifications
- Writes and executes validation (IQ/OQ/PQ) protocols and reports with limited supervision
- Develops test methods and executes test method validation
- Collects data and conducts statistical analysis using statistical evaluation tools, i.e. Minitab
Identifies and manages mitigation of product, process, and project risk according to principles of ISO 14971 Creates, edits, and reviews all engineering documentation related to assigned projects, such as technical reports, work instructions, validation and verification protocols and reports, memos, risk management plans, device history records, etc. Interacts with customers, suppliers, and internal resources
Advises, trains, and mentors junior engineers
Synthesizes critical information and complex data and clearly communicates engineering implications to project managers and project stakeholders
Provides engineering services in a phased development approach to develop & launch medical devices and the fixturing and processes required to manufacture those products
Provides guidance and technical expertise to find the root cause and fix product and process problems
Develops product and process designs and accompanying drawings and specifications
Works cooperatively with quality, manufacturing, regulatory, clinical, sales, and marketing personnel to ensure project success
Requirements:- BS in Engineering or related field (Mechanical, Biomechanical, Industrial)8+ years of related work experience in the medical device or a related field preferred
- Proficiency in computer programs for 3D modeling, i.e. SolidWorksThe ability to perform statistical analysis using k-factors, Cpk/Ppk, and DOEs along with root cause analysis (Required)
- Knowledge of geometric dimensioning and tolerancing (GD&T) preferred
- The ability to lead a team toward operational objectives with the aptitude to contribute to strategic goal-setting for a department/business unit
- Ability to function with no supervision
- Experience developing designs and testing via a phase-gate analysis (Concept, Feasibility, Verification) using a risk-based approach, including creation of risk assessments & failure modes and effects analysis (RA/FMEA)
Subject matter expertise in a directly applicable field (e.g. medical device development, mechanical assembly, catheter systems, injection molding, extrusions, electro-mechanical, etc. Design for manufacturability (DFM) preferredExperience with medical process validation, including supporting validation definition and execution (IQ, OQ, PQ), test method definition, root cause analysis, gage R&R, and measurement systems analysis (MSA) Experience and understanding of the design for plastics injection-mold fabrication processes preferred
Ability to perform statistical analysis to ensure quality output of components & assemblies preferred.
Working knowledge of Google suite of products preferred
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position. Confluent Medical Technologies is an equal opportunity employer. Only qualified candidates will be contacted.
