Senior Engineer, New Product Integration

Merz North America•Raleigh, NC

About The Position

Sr. Engineer is a product development R&D, manufacturing, and process development skilled individual that is assigned project work related to manufacturing integration of medical devices from concept to start-up manufacturing. This individual will be involved in all phases of product development as a key contributor representing product development and manufacturing. You will work with R&D, Manufacturing, Quality, Regulatory, and Marketing to ensure designs are manufacturable, evaluate potential suppliers, review new materials, and work with internal and external teams to develop, test, document, and validate the manufacturing processes, to include launch management for new products. You will also serve as a mentor and teacher to other engineers. Must have worked in a medical device company and familiar with regulatory and quality requirements throughout all stages of the product development life cycle.

Requirements

Bachelor of Engineering (B.E.) in ME or EE or other relevant Engineering discipline
6-7 years years of related design and manufacturing experience in the medical device and/or component development industry
Understanding and application of ISO Quality System requirements and FDA regulations for medical device manufacturing
Demonstrated ability to deliver results with minimal supervision

Nice To Haves

Master's Degree
MBA / Master’s in ME or EE or other relevant Engineering discipline
Familiar with project management methods and tools
Practical knowledge of Six Sigma methodologies or SPC. Green or Black Belt certification
Technical & Functional Skills
Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
Solidworks or other CAD experience
Component development knowledge qualifying components and process to meet design specifications
Experience in manufacturing and assembly process (DFM) for development and validation (IQ, OQ, PQ)
Knowledge of Injection molding, die casting, metal stamping, 3D printing and/or machining, including fixtures gauges and tooling experience
Familiar with a variety of manufacturing processes including mechanical and electromechanical
Ability to work effectively with internal and external teams
Design Control experience producing design (DFM) solutions or improvements, process verification and validation to qualify and document product(s) while implementing consistency and repeatability in the manufacturing process
Ability to support, mentor, and direct the efforts of junior level engineering staff

Responsibilities

Process Development and Validation: Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
Develop & define production control methods to monitor process output and establish critical supplier metrics.
Define and coordinate the design and development of manufacturing fixturing and test equipment.
Create Drawings, BOMs and Router documentation throughout the development cycle.
Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
Lead and support manufacturing development and transfers to contract manufacturers.
Design Controls Documentation and Product Qualification: Provide input to the User Requirements and System Requirements Documents.
Conduct Design/Process FMEA to evaluate potential failures and implement risk mitigations.
Product Transfer of Design to Production, including Warehousing and Service & Repair criteria documentation.
Ensure compliance to the requirements of ISO13485 standards, FDA/Global regulatory regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
Supplier evaluation and selection: Identify potential suppliers and perform technical evaluation for selection.
Support Supplier audits and qualifications.
Develop the team - instill leadership and accountability: Mentor and teach others about process development and the utilization of solid problem-solving methods and skills.
Problem solving and root-cause analysis.
Deliver results and create accountability